Sacituzumab Govitecan In TNBC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC)

The names of the study drugs involved in this study is:

* Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female or male patients ≥ 18 years of age.

Histologically confirmed diagnosis of invasive breast cancer, previously untreated.

Not a woman of childbearing potential (WOCBP) OR

Complete abstinence from intercourse of reproductive potential, or

Disqualifiers

Participants currently receiving systemic therapy for any malignancy or having received systemic therapy for a malignancy in the preceding 3 years. (Concurrent endocrine therapy allowed in the adjuvant setting. Concurrent GnRH agonists allowed in any setting. Concurrent CDK4/6 inhibitor not allowed in any setting.)

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.

History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.

History of cardiac failure, known cardiomyopathy (LVEF < 50%; new LVEF assessment is not specifically required for this trial), significant/symptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following: ---Known risk to prolong the QT interval or induce Torsade's de Pointes.; Uncorrected hypomagnesemia or hypokalemia; Systolic Blood Pressure (SBP) >160 mmHg or <90 mmHg. Higher blood pressure is permissible per discretion of treating physician; Bradycardia (heart rate <50 at rest), by ECG or pulse; On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >470 screening ECG

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab Govitecan

    Drug

    Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)

  • Pembrolizumab

    Drug

    Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)

Treatment groups

239 Participants
are divided into 2 treatment groups
Group A: Sacituzumab Govitecan (monotherapy cohort)Experimental treatment 1 intervention
Group B: Sacituzumab Govitecan and Pembrolizumab (combination cohort)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response(pCR) rate with sacituzumab govitecan

pCR is defined as no residual invasive carcinoma in the breast and in the lymph node. The two-sided 95% CIs for pCR rate will be calculated.

Time frame
12 Weeks

Secondary outcomes

1

Disease-Free Survival

Kaplan-Meier methods and descriptive statistics

Time frame
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
2

Overall Survival

Kaplan-Meier methods and descriptive statistics

Time frame
defined as the time from the first dose of study treatment to the date of death or last contact up to 36 months
3

Change in Breast Conserving Surgery Rate (BCS) rate

RCB calculator: http:// RCB calculator: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3

Time frame
12 Weeks
4

Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

CTCAE v5.0

Time frame
Baseline to 12 weeks

Other outcomes

Sponsors and contacts

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