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COMPLETEDPHASE1

Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)

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

NCT03109080•Institut Curie

View on ClinicalTrials.gov

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.

Detailed Description

Open label phase I, dose escalation trial for patients with triple negative inflammatory, loco-regional advanced or metastatic breast cancer either inoperable after neoadjuvant chemotherapy or operated with residual disease (after neoadjuvant chemotherapy).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Woman aged \>18 years.
•2. Histologically confirmed triple negative breast cancer with loco-regional radiotherapy indication :
•1. Non-operated with either:
•1. Inflammatory breast cancer in progression during neoadjuvant chemotherapy or inoperable after neoadjuvant chemotherapy.
•2. 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).
•3. 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.
•2. Or patient operated after neoadjuvant treatment and surgery with residual disease (non-pCR and/or pN+ disease).
•3. 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.
•4. ECOG performance status \< 2.
•5. Life expectancy greater than 6 months.
+13 more criteria

Exclusion Criteria

•1. Radiation therapy: prior history of radiation therapy to the ipsilateral breast and/or regional nodes (except prior radiation therapy to other sites).
•2. 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.
•3. 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.
•4. 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.
•5. 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.
•6. Any previous treatment with a PARP (Poly (Adenosine diphosphate \[ADP\]-Ribose) Polymerase) inhibitor, including Olaparib.
•7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Olaparib.
•8. 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.
•9. Resting ECG with QTc \> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
•10. Blood transfusions within 14 days prior to treatment start.
+5 more criteria

Locations (1)

Institut Curie

Paris, France

Key Dates

Start Date

July 24, 2017

Primary Completion Date

February 17, 2020

Completion Date

November 29, 2021

Last Updated

November 24, 2025

Enrollment

ACTUAL participants

Conditions

Breast Neoplasms, Triple-NegativeBreast Neoplasm Malignant FemaleRadiotherapy Side Effect

Interventions

Olaparib

DRUG

Radiation therapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)

Inclusion Criteria

Exclusion Criteria

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