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Monoclonal Antibodies

Sacituzumab Govitecan + Pembrolizumab for Breast Cancer (NeoSTAR Trial)

Phase 2

Recruiting

Led By Laura Spring, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Regional lymph node AJCC (v7) TNM stages N0-N2

Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2 negative (HER2-), invasive breast cancer

Must not have

Clinically significant, uncontrolled heart disease and/or cardiac reppolarization abnormality

Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the first dose of study treatment to disease recurrence/progression by recist v1.1 or death due to any cause, up to 36 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is studying sacituzumab govitecan to see how well it works in combination with pembrolizumab in treating patients with localized triple-negative breast cancer.

Who is the study for?

This trial is for adults with a specific breast cancer type called triple negative (no ER, PR, HER2 receptors), who haven't been treated yet. They must have a tumor of at least 1 cm without spread to distant parts of the body and be in good health overall. Pregnant or breastfeeding individuals, those with other cancers within 3 years, uncontrolled illnesses, HIV on antiretrovirals or certain heart conditions can't join.

What is being tested?

The study is testing Sacituzumab Govitecan alone and in combination with Pembrolizumab for treating localized triple negative breast cancer. It aims to see how well these drugs work before any standard treatments like surgery or radiation are given.

What are the potential side effects?

Sacituzumab Govitecan may cause nausea, diarrhea, hair loss, fatigue and low blood cell counts which could lead to increased infection risk. Pembrolizumab might cause immune system-related side effects affecting various organs.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread to nearby lymph nodes but not beyond.

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My breast cancer is not driven by estrogen, progesterone, or HER2.

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My blood tests show my organs and bone marrow are working well.

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I am fully active or can carry out light work.

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I have signed the consent form and can follow the study's requirements.

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My cancer has not spread to distant parts of my body.

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My breast cancer diagnosis is confirmed and I haven't received any treatment yet.

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I am a woman, regardless of my menopausal status.

Exclusion Criteria

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

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I do not have uncontrolled heart disease or abnormal heart rhythms.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am not on systemic therapy for another cancer nor have I been in the last 3 years.

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I am HIV-positive and on antiretroviral therapy.

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My breast cancer is either inflammatory or has come back in the same area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the first dose of study treatment to disease recurrence/progression by recist v1.1 or death due to any cause, up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the first dose of study treatment to disease recurrence/progression by recist v1.1 or death due to any cause, up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the first dose of study treatment to disease recurrence/progression by recist v1.1 or death due to any cause, up to 36 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

Pathological complete response(pCR) rate with sacituzumab govitecan

Secondary study objectives

Assessment of Quality of life (QOL)

Change in Breast Conserving Surgery Rate (BCS) rate

Disease-Free Survival

+2 more

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sacituzumab Govitecan and Pembrolizumab (combination cohort)Experimental Treatment2 Interventions

- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles. * Pembrolizumab via iv, predetermined dosage per protocol, IV, 1 day per each 21-day cycle, for 4 cycles. * This can be followed by standard chemotherapy at the discretion of treating physician.

Group II: Sacituzumab Govitecan (monotherapy cohort)Experimental Treatment1 Intervention

- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles. * This can be followed by standard chemotherapy at the discretion of treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Sacituzumab govitecan

FDA approved

0 / 13Eligibility criteria met