Skip to main content

8110 Gatehouse Road, Falls Church, VA 22042

A Phase II, Single-Arm, Open-Label Study of Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients with Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (G1T28-213)

Translate

General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT05113966

Background Information

The purpose of this study is to evaluate progression free survival (the length of time during and after treatment a participantt lives with cancer and the cancer does not get worse) when the study medication, trilaciclib (COSELA™) is administered prior to sacituzumab govitecan-hziy (TRODELVY®) in participants with advanced or metastatic (cancer has spread to other parts of the body) TNBC. Sacituzumab govitecan-hziy is a form of chemotherapy approved by the U.S. FDA for the treatment of advanced or metastatic TNBC. All participants enrolled in this study will receive trilaciclib (now referred to as “study medication”) prior to sacituzumab govitecan-hziy.

The study will also evaluate the impact of the study medication on how long participants live, how participants’ tumors respond to treatment, effects on the bone marrow and the blood cells developed by bone marrow, and the safety and tolerability of the study medication when administered prior to sacituzumab govitecan-hziy.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital

Inova Schar Cancer Institute
3580 Joseph Siewick Drive
Fairfax, VA 22033

Eligibility Information

  • Age 18 years of age or older
  • Measurable, unresectable locally advanced or metastatic TNBC
  • Participants must have received 2 or more prior lines of systemic therapy, at least one of them in the metastatic setting
  • Additional eligibility in protocol

Ineligibility Information

  • Prior treatment with trilaciclib, sacituzumab govitecan-hziy, irinotecan, Trop-2 antibody drug conjugate, or any therapy with a topoisomerase-1 payload
  • Known brain metastasis at enrollment
  • Known Gilbert’s disease or known homozygous for the UGT1A1*28 allele
  • Bone-only disease
  • Women who are pregnant/breastfeeding
  • Additional ineligibility in protocol

For additional information, please see: https://www.clinicaltrials.gov/ct2/show/NCT05113966