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OncoMatch/Clinical Trials/NCT04090567

Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer

Is NCT04090567 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cediranib and Ceralasertib for advanced breast carcinoma.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT04090567Data as of May 2026

Treatment: Cediranib · Ceralasertib · OlaparibThis phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic). Olaparib, cediranib, and AZD6738 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: BRCA1 germline mutation

BRCA germline positive breast cancer

Required: BRCA2 germline mutation

BRCA germline positive breast cancer

Required: HER2 (ERBB2) wild-type

HER2 negative

Disease stage

Required: Stage III, IIIA, IIIB, IIIC, IV (AJCC v8)

Metastatic disease required

advanced/metastatic HER2 negative, BRCA germline positive breast cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: PARP inhibitor — (neo)adjuvant or metastatic

Patient should have previously treated with any PARP inhibitor ((neo)adjuvant or metastatic) setting) and must have remained on treatment for e/= 2 months prior to progression of disease.

Must have received: endocrine therapy

Estrogen receptor positive (ER+) patients must have progressed on a prior endocrine therapy or are considered inappropriate for any FDA approved endocrine therapies for ER+ breast cancer.

Cannot have received: Ceralasertib (Ceralasertib)

Prior exposure to Ceralasertib

Lab requirements

Blood counts

Hemoglobin (Hgb) ≥ 10.0 g/dL with no blood transfusion in the past 28 days; ANC ≥ 1.5 x 10^9/L with no GCSF administration within 28 days; Platelet count ≥ 100 x 10^9/L

Liver function

Total bilirubin ≤ 1.5 x institutional ULN; AST/ALT ≤ 3.0 x ULN unless liver metastases are present in which case ≤ 5x ULN

Patients must have normal organ and bone marrow function measured within 28 days (baseline screening) as defined below: Hemoglobin (Hgb) ≥ 10.0 g/dL with no blood transfusion in the past 28 days prior to the administration; Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L with no GCSF administration within 28 days prior to administration of study treatment; Platelet count ≥ 100 x 10^9/L; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤3.0 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤5x ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • M D Anderson Cancer Center · Houston, Texas

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