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Antimetabolites

Sacituzumab Govitecan + Pembrolizumab for Triple Negative Breast Cancer (ASCENT-05 Trial)

Phase 3

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery

Must not have

Active serious infections requiring anti-microbial therapy

Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 96 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test if a new combination of drugs is more effective and safer than standard treatments for triple negative breast cancer.

Who is the study for?

This trial is for adults over 18 with triple negative breast cancer that remains after pre-surgery treatment and surgery. They must have completed any needed radiotherapy, be in good physical condition (ECOG 0-1), and have proper organ function. Excluded are those with recurrent or stage IV cancer, prior treatments with certain drugs, known BRCA mutations, recent serious heart issues, severe infections, or previous immunotherapy.

What is being tested?

The study compares the effectiveness of sacituzumab govitecan-hziy (SG) combined with pembrolizumab to the physician's choice of treatment post-surgery for patients with residual triple negative breast cancer. The physician's choice may include pembrolizumab alone or combined with capecitabine.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, fatigue, nausea and vomiting from chemotherapy agents like capecitabine; SG might cause low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am over 18 and have triple negative breast cancer remaining after treatment and surgery.

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I have had surgery to remove all visible cancer in my breast or lymph nodes and have recovered.

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I have provided samples from before and after my cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for a serious infection.

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I have not been treated with specific immune system drugs or HER2-targeted therapies before.

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I haven't had a heart attack or severe heart issues in the last 6 months and my heart pumps well.

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My cancer has come back after initial treatment and surgery.

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I have stage IV breast cancer and a history of breast cancer on either side.

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I have been treated with drugs targeting DNA enzymes or ADCs with a DNA enzyme inhibitor.

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I have a known BRCA gene mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 96 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 96 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Invasive Disease-free Survival (iDFS)

Secondary study objectives

Distant Disease-free Survival (dDFS)

Overall Survival (OS)

Recurrence-free Survival (RFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sacituzumab govitecan-hziy (SG) + PembrolizumabExperimental Treatment2 Interventions

Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.

Group II: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + CapecitabineActive Control2 Interventions

Participants will receive one of the following TPC regimens determined prior to randomization: * Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR * Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m\^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

0 / 11Eligibility criteria met