OncoMatch/Clinical Trials/NCT06263543
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
Is NCT06263543 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sacituzumab govitecan for breast cancer.
Treatment: Sacituzumab govitecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) HER2 low (IHC 2+/ISH- or IHC 1+ (ISH- or untested))
HER2 LOW is defined as: (IHC 2+/ISH- or IHC 1+ (ISH- or untested))
Required: HER2 (ERBB2) HER2 ultra low (IHC0+ (faint membrane staining up to 10%))
HER2 ULTRA LOW is defined as: IHC0+ (faint membrane staining up to 10%)
Required: ESR1 estrogen receptor positive (>1%) (>1%)
hormone receptor positive (estrogen receptor and/or progesterone receptor positive) defined as >1% on any metastatic site or the primary tumor
Required: PR (PGR) progesterone receptor positive (>1%) (>1%)
hormone receptor positive (estrogen receptor and/or progesterone receptor positive) defined as >1% on any metastatic site or the primary tumor
Disease stage
Required: Stage IV, ADVANCED AND UNRESECTABLE
Excluded: Stage LOCALLY ADVANCED MBC (STAGE IIIC) IN INDIVIDUALS WHO ARE CANDIDATES FOR CURATIVE INTENT THERAPY
Metastatic disease required
Histologically confirmed metastatic or advanced and unresectable breast cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: CDK4/6 inhibitor — adjuvant or metastatic
Received a CDK4/6 inhibitor either alone or in combination with endocrine therapy (in the adjuvant or metastatic setting) with any duration of therapy permitted
Must have received: antibody-drug conjugate (T-DXd)
Prior treatment with T-DXd (discontinued for progression and/or intolerance), which does not have to be the treatment immediately prior to enrollment on trial
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dL (no transfusion within 1 week prior to screening); ANC ≥ 1500/mm^3 (no G-CSF within 1 week prior to screening); Platelet count ≥ 100,000/mm^3 (no transfusion within 1 week prior to registration)
Kidney function
Creatinine clearance (CrCl) ≥ 30 mL/min (Cockcroft-Gault equation)
Liver function
Total bilirubin ≤ 1.5 × ULN if no liver metastases or < 3 × ULN in the presence of documented Gilbert's Syndrome or liver metastasis at baseline; ALT and AST ≤ 3 × ULN or < 5 × ULN in patients with liver metastasis; serum albumin ≥ 2.5 g/dL
Adequate organ and bone marrow function within 28 days before enrollment. Hemoglobin ≥ 9 g/dL. ANC ≥ 1500/mm^3. Platelet count ≥ 100,000/mm^3. Total bilirubin ≤ 1.5 × ULN if no liver metastases or < 3 × ULN in the presence of documented Gilbert's Syndrome or liver metastasis at baseline. ALT and AST ≤ 3 × ULN or < 5 × ULN in patients with liver metastasis. Serum albumin ≥ 2.5 g/dL. Creatinine clearance (CrCl) ≥ 30 mL/min. INR or PT and either PTT or aPTT ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Jonsson Comprehensive Cancer Center · Los Angeles, California
- Miami Cancer Institute at Baptist Health, Inc. · Miami, Florida
- Winship Cancer Institute at Emory University · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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