Sacituzumab Govitecan In TNBC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04230109
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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)

Key Dates

Start date
Jul 14, 2020
Status verified
May 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab Govitecan (monotherapy cohort)
    \- 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.
  • Experimental: Sacituzumab Govitecan and Pembrolizumab (combination cohort)
    \- 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.

Primary Outcome Measure

Pathological complete response(pCR) rate with sacituzumab govitecan [ Time Frame: 12 Weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115
Neelam Desai, MD
617-667-2100
Neelam Desai, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Sara Tolaney, MD, MPH
617-632-3800
Sara Tolaney, MD, MPH (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02115
Laura Spring, MD
[email protected]
617-726-6500
Laura Spring, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital - North Shore Cancer CenterDanversMassachusetts01923
Therese Mulvey, MD
978-882-6060
Therese Mulvey, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital at Newton-Wellesley HospitalNewtonMassachusetts02462
Amy Comander, MD
617-219-1230
Amy Comander, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAMassachusetts General Hospital - North Shore Cancer Center· Danvers, MAMassachusetts General Hospital at Newton-Wellesley Hospital· Newton, MA

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