Study on Olaparib and Durvalumab for HER2 Negative BRCA-Mutated Breast Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT05498155
This clinical trial is exploring the use of the drug olaparib, alone and in combination with durvalumab, to treat HER2-negative breast cancer with BRCA mutations. The study aims to understand how these treatments work and their effects on breast cancer.
Patient Parameters
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Program Overview
This study is investigating how well the drug olaparib, both on its own and combined with durvalumab, works in treating HER2-negative breast cancer with BRCA mutations. Olaparib is a type of medication known as a PARP inhibitor, which helps destroy cancer cells that can't repair DNA damage. Durvalumab is an immunotherapy drug that helps the immune system attack cancer cells. While olaparib is already approved for certain breast cancers, the combination with durvalumab is still being studied for breast cancer treatment.
Description
The study is looking at how effective olaparib is when used alone or with durvalumab in patients with early-stage BRCA-mutated, estrogen receptor (ER)-negative or low, HER2-negative breast cancer. These patients are candidates for treatment before surgery (neoadjuvant therapy). The goal is to find new treatments that can improve the chances of completely eliminating cancer and increasing survival without events. For patients with a lower risk of cancer returning, olaparib alone might be enough. However, for those at higher risk, adding durvalumab might improve long-term outcomes. The study also aims to find ways to reduce the need for traditional chemotherapy. While the effectiveness of the olaparib and durvalumab combination is still being studied, there is enough information to understand its safety and tolerability.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older
- Weigh at least 30 kg
- Able to give informed consent
- Must use effective contraception if of childbearing potential
- Newly diagnosed, primary, operable, non-metastatic invasive breast cancer with specific characteristics:
- ER-negative or ER-low (≤10% staining)
- HER2-negative (not eligible for anti-HER2 therapy)
- Clinical staging as follows:
- T1b (>5 mm but ≤10 mm), N0, no known metastases
- T1c (>10 mm but ≤20 mm), N0, no known metastases
- T1 (>1 mm but ≤20 mm), N1, no known metastases
- T2 (>20 mm but ≤50 mm), N0, no known metastases
- Documented BRCA1 or BRCA2 mutation
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function
- Willing to undergo a baseline research biopsy and submit leftover tumor tissue for research, if available.
Exclusion Criteria
- Other severe or uncontrolled diseases or infections
- Difficulty swallowing or chronic gastrointestinal issues
- History of another primary cancer unless treated with no active disease for 5 years
- Participants with MDS or AML
- For higher risk participants: Active or prior autoimmune or inflammatory disorders
- Active hepatitis infection or positive for hepatitis C or B
- Positive for HIV unless on effective treatment
- History of certain heart rhythm issues
- No prior treatment for current breast cancer
- For higher risk participants: Prior exposure to certain immune therapies
- Any concurrent cancer treatment
- Major surgery within 2 weeks of starting study treatment
- For higher risk participants: Recent use of immunosuppressive medication
- Use of certain medications affecting liver enzymes within specified timeframes before starting the study
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 80631 | Greeley | Colorado |
| Research Site | 80537 | Loveland | Colorado |
| Research Site | 02215 | Boston | Massachusetts |
| Research Site | 97239 | Portland | Oregon |
| Research Site | 19104 | Philadelphia | Pennsylvania |
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