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Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Collaborator: Merck Sharp & Dohme Corp.

Intervention(s):

  • Drug: Olaparib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
   that is one of the following phenotypes:

      1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative
      (not eligible for anti-HER2 therapy)

      2. ER and/or PgR positive, HER2 negative

   - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
   suspected deleterious (known or predicted to be detrimental/lead to loss of function).

   - Completed adequate breast and axilla surgery.

   - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing
   anthracyclines, taxanes or the combination of both. Prior platinum as potentially
   curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant
   treatment for breast cancer is allowed.

   - ECOG 0-1.

Exclusion criteria:

   - Any previous treatment with a PARP inhibitor, including olaparib and/or known
   hypersensitivity to any of the excipients of study treatment.

   - Patients with second primary malignancy. EXCEPTIONS are:

      1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of
      the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1
      endometrial carcinoma

      2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5
      years prior to randomisation and treated with no evidence of disease recurrence
      and for whom no more than one line of chemotherapy was applied.

   - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole,
   ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

   - Evidence of metastatic breast cancer

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting