Platinum and PARP inhibitor for Neoadjuvant treatment of Triple NEgative and/or BRCA positive breast cancer

Phase 1

• Conditions: ER negative and HER2 negative Early Breast Cancer or BRCA 1 or 2 germline mutated Early Breast Cancer; MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002811-13-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-01
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 527

Inclusion Criteria

For the PARTNER trial:
•Written informed consent
•Aged between 16 and 70
•Histologically confirmed invasive breast cancer
•Clinical stage T1-4 N0-2 (tumour or metastatic node diameter > 10mm)
•Confirmed ER-negative and HER2-negative
or
•Germline BRCA mutation positive, irrespective of hormone status but HER2 negative.
•Performance Status 0-1

For the PARTNERING pathway:
• Previous inclusion and treatment within PARTNER trial
•Written informed consent (PARTNERING consent)
•Performance Status 0-1 at registration into PARTNERING
•Availability of an end of chemotherapy biopsy after cycle 6 and prior cycle 7 of PARTNER treatment
•Histologically confirmed residual invasive breast cancer at biopsy performed after Cycle 6 of PARTNER therapy
•Availability of TILs assessment in baseline biopsy prior Cycle 1 AND post Cycle 6 of PARTNER therapy is required
•Body weight >30kg
•Adequate bone marrow, hepatic, and renal function

Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 506
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

For the PARTNER trial:
• T0 tumour in absence of axillary node > 10mm
•TNBC with a non-basal phenotype and over-expressing Androgen Receptor
•Not suitable for neoadjuvant chemotherapy
•Distant metastases apparent prior to randomisation
•Prior history of invasive breast cancer within the last 5 years
•Previous PARP inhibitor use or any previous chemotherapy or targeted agent
•Any previous chemotherapy or agent used for the treatment of cancer within the last 5 years

For the PARTNERING pathway:
•Rapidly progressive disease during PARTNER neoadjuvant treatment
•Tumour cellularity less than 10% in biopsy performed after Cycle 6 of PARTNER therapy.
•Not suitable for treatment with new agents
•Persistent AEs from prior anti-cancer therapy =Grade 3

Study & Design

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