Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT04090567

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

Led by M.D. Anderson Cancer Center · Updated on 2026-03-05

60

Participants Needed

1

Research Sites

387 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women over 18 years old with advanced or metastatic HER2-negative breast cancer carrying a germline BRCA mutation
  • Estrogen receptor positive patients must have progressed on or be unsuitable for approved endocrine therapies
  • Agreement to mandatory fresh biopsy at screening and provision of archival tissue if available
  • Normal organ and bone marrow function based on recent lab tests
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 16 weeks
  • Negative pregnancy test for women of childbearing potential and use of effective contraception
  • Willingness and ability to comply with study procedures and visits
  • Measurable disease with at least one lesion suitable for accurate measurement by CT or MRI
  • Willingness to undergo baseline biopsy and research blood draws
  • Prior treatment with a PARP inhibitor for at least 2 months before disease progression
  • Ability to swallow and absorb oral medications
  • Non-English speaking individuals may participate
Not Eligible

You will not qualify if you...

  • Chemotherapy or radiation therapy within 3 weeks (or less than 1 week for weekly chemotherapy) before starting study drugs or unresolved toxicities from prior treatments
  • Use of other investigational agents within the past 4 weeks
  • Untreated brain metastases or symptomatic brain/spinal metastases
  • Allergic reactions to drugs similar to olaparib or ceralasertib
  • Use of medications that strongly affect CYP3A4 unless stopped during required washout periods
  • Use of herbal or alternative medicines within 7 days before starting study drugs
  • Other invasive cancers diagnosed within the past 5 years except certain skin or in situ cancers
  • Uncontrolled illnesses or infections that may interfere with study participation
  • Recent heart attack, stroke, or serious cardiac conditions
  • Significant vascular diseases such as large abdominal aortic aneurysms unless stable and asymptomatic
  • Major surgery or significant injury within 28 days before starting study drugs
  • Recent bowel obstruction, significant bleeding, lung abscess, or certain gastrointestinal conditions
  • Dependency on intravenous hydration or total parenteral nutrition
  • Signs of blood disorders or active infections like hepatitis or HIV
  • Inability to swallow oral medications or gastrointestinal disorders affecting absorption
  • Prior exposure to ceralasertib
  • Uncontrolled seizures
  • Certain abnormal heart rhythms or conditions
  • Risk factors for brain blood flow problems
  • Low blood pressure or uncontrolled hypertension
  • Pregnancy, breastfeeding, or lactation
  • Prior bone marrow or umbilical cord blood transplant
  • Diagnosis of ataxia telangiectasia
  • Major surgery within 3 weeks before starting treatment without full recovery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

B

Banu Arun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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