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Phase 2 Study of Pembrolizumab+Carboplatin in Breast Related Cancer Antigens-related Metastatic Breast Cancer (PEMBRACA)

NCT03732391 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-01-31

No results posted yet for this study

Summary

This is a prospective two-stage single arm phase II study to be conducted in conformance with Good Clinical Practices.

This study will enrol 53 patients, based on a two steps Simon's design.

Patients will entry into the study if the following conditions will be satisfied:

* BRCA1/2 germline mutations.
* Metastatic disease with measurable lesions will be evaluated by computed tomography or by PET (Positron Emission Tomography) scan.
* Patients must have received anthracycline and taxanes before entry into the study.

Patients will be treated with Carboplatin AUC6 (Area Under The Curve) EV (endovenous) every 3 weeks in combination with Pembrolizumab 200 mg EV every 3 weeks for 6 cycles. Afterwards, the Pembrolizumab will recontinued with the same schedule until unacceptable toxicity or disease progression.

The primary endpoint will be Objective Responses Rate (ORR) (complete answers + partial answers) evaluated according to the RECIST criteria.

Conditions

Interventions

DRUG

Pembrolizumab 25 MG(milligram)/ML

Carboplatin AUC6 EV will be given every 3 weeks in combination with Pembrolizumab 200 mg EV every 3 weeks for 6 cycles. Afterwards, the Pembrolizumab will be continued with the same schedule until unacceptable toxicity or disease progression

Sponsors & Collaborators

  • CORTESI LAURA

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2022-06-30
Completion
2023-01-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732391 on ClinicalTrials.gov