Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC

NCT06263543 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2023-MAH-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

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

Metastatic Breast Cancer; Advanced Breast Cancer; Human Epidermal Growth Factor 2 Low Breast Cancer; Breast Cancer; Hormone-receptor-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  ORR will be assessed using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). ORR is defined as the percentage of participants who received at least one dose of SG and have achieved a complete response (CR) or partial response (PR) as assessed by the local investigator.

  24 months

Secondary Outcomes (8)

• Clinical benefit rate (CBR)

  24 months

• Progression-free survival (PFS)

  30 months

• Overall survival (OS)

  30 months

• Duration of response (DOR)

  30 months

• Global Quality of Life

  24 months

Study Arms (1)

Sacituzumab Govitecan (SG) Infusion

EXPERIMENTAL

SG will be administered on Days 1 and 8 of continuous 21-day cycles at 10 mg/kg via intravenous (IV) infusion until disease progression or unacceptable toxicity.

Drug: Sacituzumab govitecan

Interventions

Sacituzumab govitecan DRUG

IV infusion of 10 mg/kg on Days 1 and 8 of each continuous and consecutive 21-day cycles. The first infusion will last approximately 3 hours and subsequent infusions will last 1-2 hours if prior infusions were well tolerated.

Also known as: Trodelvy

Sacituzumab Govitecan (SG) Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Individuals ≥ 18 years of age.
• \. Histologically confirmed metastatic or advanced and unresectable breast cancer that is HER2 LOW/ULTRA LOW by local testing on either the primary or any metastatic site. HER2 LOW is defined as: (IHC 2+/ISH- or IHC 1+ (ISH- or untested)) and HER2 ULTRA LOW is defined as: IHC0+ (faint membrane staining up to 10%)
• Histologically confirmed metastatic or advanced and unresectable breast cancer that is hormone receptor positive (estrogen receptor and/or progesterone receptor positive) defined as \>1% on any metastatic site or the primary tumor.
• Endocrine-refractory (as per investigator judgement) and may have received any number of prior endocrine therapies (alone or in combination with cyclin-dependent kinase (CDK)4/6 inhibitor, everolimus, alpelisib, acapivasertib or inavolisib).
• 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.
• Received at least 1 but no more than 4 prior systemic chemotherapy regimens in the metastatic setting. Prior ADCs count as a line of systemic chemotherapy. Prior PARP inhibitor use counts as a line of systemic therapy.
• 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.
• Documented clinical and/or radiographic disease progression after most recent therapy, unless immediate prior therapy was T-DXd which was discontinued for toxicity.
• Measurable disease, as per RECIST V1.1 - a. If a patient has bone-only disease, they are eligible as long as there is a lytic lesion that is considered measurable. Blastic-only bone lesions are not allowed.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
• Adequate organ and bone marrow function within 28 days before enrollment. For all parameters listed below, the most recent results available must be used:
• Hemoglobin ≥ 9 g/dL. Note: Red blood cell transfusion is not allowed within 1 week prior to screening assessment.
• Absolute neutrophil count (ANC) ≥ 1500/mm\^3. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment.

You may not qualify if:

• Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
• Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline/screening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post receipt of surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment.
• Active serious infection requiring ongoing antibiotics.
• History of an anaphylactic reaction to irinotecan.
• Pregnant or breastfeeding.
• Ongoing treatment with another investigational drug or other interventional trial.
• Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
• Any other condition that may put a participant at higher risk, at the discretion of the investigator.

Sponsors & Collaborators

• Gilead Sciences: collaborator
• Reshma L. Mahtani, D.O.: lead

Study Sites (3)

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90404, United States

NOT YET RECRUITING

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

RECRUITING

Winship Cancer Institute at Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Related Publications (2)

• Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.

  PMID: 32223649 BACKGROUND

• Schmid P, Cortés J, Marmé F, Rugo HS, Tolaney SM, Oliveira M, Loirat D, Jhaveri K, Yoon OK, Motwani M, Wang H, Delaney RJ, Bardia A. Sacituzumab govitecan (SG) efficacy in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC) by HER2 immunohistochemistry (IHC) status in the phase III TROPiCS-02 study. Annals of Oncology. 2022; 33(Suppl7): S635-636.

  BACKGROUND

Related Links

• Miami Cancer Institute

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Reshma L Mahtani, D.O.

  Miami Cancer Institute at Baptist Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reshma L Mahtani, D.O.

CONTACT

(786) 596-2000; rmahtani@baptisthealth.net

Krystal Fernandez

CONTACT

(786) 596-2000; krystal.fernandez@baptisthealth.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Breast Medical Oncology

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 16, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)