A multicenter phase II trial to evaluate the efficacy and safety ofpembrolizumab and gemcitabine in patients with HER2-negative Advanced Breast Cancer (ABC). PANGEA-Breast” - PANGEA-Breast

GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)0 sites36 target enrollmentNovember 18, 2016

ConditionsPatients with HER2-negative advanced breast cancer.MedDRA version: 19.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with HER2-negative advanced breast cancer.
Sponsor: GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
Enrollment: 36
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 18, 2016

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)

Eligibility Criteria

Inclusion Criteria

•1\. The patient has signed and dated the informed consent document and it has been obtained before conducting any procedure specifically for the study.
•2\. Female \= 18 years of age on day of signing informed consent.
•3\. Histological/cytological confirmation of breast cancer with evidence of advanced disease, not amenable to resection or radiation therapy with curative intent.
•4\. Documented luminal A, luminal B (HER2\-negative) or triple negative disease by
•immunohistochemistry (IHQ) and/or in situ hybridization (FISH/CISH/SISH) based on
•local testing on the most recent tumour biopsy defined as follows:
•o Luminal A: tumour with positive oestrogen receptor (ER) status (\>1% of tumour cells with ER expression) and HER2\-negative status (IHQ score 0/1\+ or negative by in situ hybridization defined as a HER2/CEP17 ratio \< 2 or for single probe assessment a HER2 copy number \< 4\) and high progesterone receptor (PgR) (\> 20% of tumour cells with PgR expression) and low Ki67 (\< 14%).
•o Luminal B (HER2\-negative): tumour with positive ER status (\>1% of tumour cells with ER expression) and HER2\-negative status (IHQ score 0/1\+ or negative by in situ hybridization defined as a HER2/CEP17 ratio \< 2 or for single probe assessment a HER2 copy number \< 4\) and either low or negative PgR (\< 20% of tumour cells with PgR expression) and/or high Ki67 (\= 14%).
•o Triple negative: tumour with negative hormone receptor status (\<1% of tumour
•cells with ER and PgR expression) and HER2\-negative status (IHQ score 0/1\+ or negative by in situ hybridization defined as a HER2/CEP17 ratio \< 2 or for single probe assessment a HER2 copy number \< 4\).

Exclusion Criteria

•1\. HER2\-positive disease by immunohistochemistry or in situ hybridation (FISH\-SISHCISH).
•2\. Patient is currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug/medication.
•3\. Has had a prior anti\-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., \= grade 1 or at baseline) from adverse events due to
•agents administered more than 4 weeks earlier.
•4\. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., \= grade 1 or at baseline) from adverse events due to a previously administered agent.
•o Note: Patients with \= grade 2 neuropathy are an exception to this criterion and may
•qualify for the study.
•o Note: If patient received major surgery, they must have recovered adequately from
•the toxicity and/or complications from the intervention prior to starting therapy.
•5\. Has received prior therapy with an anti\-PD\-1, anti\-PD\-L1, or anti\-PD\-L2 agent.