Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2033-12-01

Brief Summary

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Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ddAC-CP-Olaparib

ddAC; doxorubicin 60 mg/m² as an i.v. bolus and cyclophosphamide 600 mg/m² as an i.v. bolus on day 1 every 2 weeks ddAC must be supported with prophylactic pegfilgrastim 6 mg s.c. given 24-48 hours after completion of administration of EVERY chemotherapy cycle

CP; carboplatin/paclitaxel (CP) consisting of carboplatin (AUC 6) on day 1 and paclitaxel (80 mg/m2) on day 1,8 and 15 of a 21 days cycle. In total 4 courses of CP will be administered.

Olaparib will be administered in Dutch centers only, as monotherapy for one year at a dose of 300 mg BID, starting 3 weeks after adjuvant radiotherapy, or, if radiotherapy is not indicated, 3-5 weeks after the last CP cycle.

Patients without a (near) pCR will receive adjuvant capecitabine at a starting dose of 1000-1250 mg/m2, twice a day, on days 1-14 every 3 weeks for eight cycles.

Group Type ACTIVE_COMPARATOR

ddAC-CP-Olaparib

Intervention Type DRUG

ddAC-CP-Olaparib

ddAC-mini CTC

ddAC; doxorubicin 60 mg/m² as an i.v. bolus and cyclophosphamide 600 mg/m² as an i.v. bolus on day 1 every 2 weeks ddAC must be supported with prophylactic pegfilgrastim 6 mg s.c. given 24-48 hours after completion of administration of EVERY chemotherapy cycle

intensified alkylating 'mini' CTC (2x) cyclophosphamide 3000 mg/m2 day 1 mesna 500 mg (push) + 2000 mg in 24 hours day 1 carboplatin (400 mg/m2; (or AUC=5 in patients with a calculated creatinine-clearance of \<100 ml/min)) days 1,2 thiotepa 250 mg/m2 day 2

Patients without a (near) pCR will receive adjuvant capecitabine at a starting dose of 1000-1250 mg/m2, twice a day, on days 1-14 every 3 weeks for eight cycles.

Group Type ACTIVE_COMPARATOR

ddAC-mini CTC

Intervention Type DRUG

ddAC - mini CTC

Interventions

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ddAC-CP-Olaparib

Intervention Type DRUG

ddAC-mini CTC

ddAC - mini CTC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women and men with stage III adenocarcinoma of the breast harboring signs of a breast cancer with features of homologous recombination deficiency (HRD)
* Age of 18-65 years
* The tumor must be HER2-negative
* Treatment must start within 8 weeks after the last surgical resection
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria

* Previous radiation therapy
* Previous chemotherapy
* Any previous treatment with a PARP-inhibitor, including olaparib
* Pre-existing neuropathy from any cause in excess of Grade 1
* Chronic concomitant use of known strong or moderate CYP3A inducers

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No