Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy

Phase 1

• Conditions: High risk breast cancer (stage III), BRCA1-like; MedDRA version: 19.0Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002493-13-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-15
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• =18 and <66 years of age and fit to undergo autologous stem cell transplantation
• Histologically confirmed adenocarcinoma of the breast
• Clinical or pathological stage III breast cancer (according to AJCC staging manual 7th edition; Stage IIIA: T0-2N2 or T3N1-2; Stage IIIB: T4N0-2; Stage IIIC: any TN3)
• The tumor must be HER2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization [CISH or FISH] in case of score 2 or 3 at immunohistochemistry)
• In the case of neoadjuvant chemotherapy: Adequate locoregional surgery and radiotherapy, including the axilla has been planned
• In the case of adjuvant chemotherapy: Having undergone radical breast conserving surgery or a mastectomy plus adequate oncological treatment of the axilla (given or planned), and adequate adjuvant radiotherapy has been planned, but has not yet been given
• Treatment must start within 8 weeks after the last surgical resection in case of adjuvant chemotherapy
• World Health Organisation (WHO) performance status 0 or 1
• Adequate hematologic, renal, and hepatic function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 174
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Previous radiation therapy
• Previous chemotherapy
• Previous treatment with a PARP-inhibitor, including olaparib
• A history of uncontrolled seizure disorder
• Pre-existing neuropathy from any cause in excess of Grade 1
• Known history of allergic reaction to cremophor/paclitaxel
• Clinically significant uncontrolled condition(s)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified