Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC) (NCT03109080) | Clinical Trial Compass
CompletedPhase 1
Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)
France24 participantsStarted 2017-07-24
Plain-language summary
A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC with Residual Disease.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Woman aged \>18 years.
✓. Histologically confirmed triple negative breast cancer with loco-regional radiotherapy indication :
✓. Non-operated with either:
✓. Inflammatory breast cancer in progression during neoadjuvant chemotherapy or inoperable after neoadjuvant chemotherapy.
✓. Loco-regional advanced breast cancer in progression during neoadjuvant chemotherapy or inoperable after neoadjuvant chemotherapy (T ≥ 3 and/or N ≥ 1; with evaluable disease according to RECIST 1.1 criteria).
✓. Non operable metastatic breast cancer (all T, all N, M1; with evaluable disease according to RECIST 1.1 criteria) needing local and regional treatment in case of good metastatic control after chemotherapy.
✓. Or patient operated after neoadjuvant treatment and surgery with residual disease (non-pCR and/or pN+ disease).
✓. Neoadjuvant chemotherapy (containing anthracyclines or taxanes or the combination of both or containing platinum-based chemotherapy) willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, and targeted therapies at least two weeks prior to start of Olaparib.
Exclusion criteria
✕. Radiation therapy: prior history of radiation therapy to the ipsilateral breast and/or regional nodes (except prior radiation therapy to other sites).
✕. Patient with unresolved or unstable, NCI-CTCAE v4.03 (National Cancer Institute Common Toxicity Criteria for Adverse Events) Grade 3 or greater toxicity from prior administration of prior anti-cancer treatment.
What they're measuring
1
Determination of the Maximal Tolerated Dose of Olaparib administered with concurrent loco regional radiotherapy
✕. Patient with clinically and uncontrolled significant comorbidity: major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to: active uncontrolled infection; symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; any other illness condition(s) that could exacerbate potential toxicities, require excluded therapy for management, or limit compliance with study requirements.
✕. Patient with second primary cancer, except : adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
✕. Concomitant anti-cancer treatment during protocol treatment and/or not completed at least 2 weeks prior to Olaparib initiation, except bisphosphonates and RANK inhibitors without restriction even during protocol treatment as long as these where started at least 4 weeks prior to study treatment initiation.
✕. Any previous treatment with a PARP (Poly (Adenosine diphosphate \[ADP\]-Ribose) Polymerase) inhibitor, including Olaparib.
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Olaparib.
✕. Patient being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritonavir, Telithromycin) within the last 7 days before first Olaparib intake.