Actively Recruiting
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
Led by Reshma L. Mahtani, D.O. · Updated on 2025-12-26
75
Participants Needed
3
Research Sites
128 weeks
Total Duration
On this page
Sponsors
R
Reshma L. Mahtani, D.O.
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd.
CONDITIONS
Official Title
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided.
- Willingness to comply with all study procedures and availability for the entire study duration.
- Age 18 years or older.
- Histologically confirmed metastatic or advanced unresectable breast cancer that is HER2 LOW/ULTRA LOW by local testing.
- Hormone receptor positive breast cancer with estrogen and/or progesterone receptor positivity greater than 1%.
- Endocrine-refractory disease with any number of prior endocrine therapies allowed.
- Prior use of CDK4/6 inhibitor alone or with endocrine therapy.
- Received between 1 to 4 prior systemic chemotherapy regimens for metastatic disease; prior antibody drug conjugates and PARP inhibitors count as chemotherapy lines.
- Prior treatment with trastuzumab deruxtecan (T-DXd), discontinued due to progression or intolerance.
- Documented clinical or radiographic disease progression after the last therapy unless T-DXd was discontinued for toxicity.
- Measurable disease as per RECIST V1.1; bone-only disease allowed if lytic lesion measurable.
- ECOG Performance Status of 0, 1, or 2.
- Adequate organ and bone marrow function within 28 days before enrollment, including specified blood counts and liver/kidney function.
- Adequate treatment washout periods before randomization for surgery, radiation, hormonal therapy, targeted therapy, immunotherapy, and T-DXd.
- Evidence of post-menopausal status or negative pregnancy test for individuals of childbearing potential.
- Agreement to use effective contraception if sexually active and of childbearing potential.
- Male participants sexually active with partners of childbearing potential must use condoms with spermicide.
You will not qualify if you...
- Locally advanced metastatic breast cancer (stage IIIc) when curative intent therapy is possible.
- Presence of brain metastases unless asymptomatic, treated, stable, and not requiring corticosteroids.
- Active serious infection needing ongoing antibiotics.
- History of anaphylactic reaction to irinotecan.
- Pregnant or breastfeeding.
- Current treatment with another investigational drug or participation in another interventional trial.
- Other medical or psychiatric conditions that may interfere with study participation or interpretation.
- Any other condition deemed by the investigator to increase risk or prevent study completion.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90404
Not Yet Recruiting
2
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
3
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
R
Reshma L Mahtani, D.O.
CONTACT
K
Krystal Fernandez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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