First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.

NCT07299409 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SG6978
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the drug Sacituzumab govitecan (SG) reduces disease progression when used as a first-line treatment in adults with advanced triple-negative breast cancer (TNBC) who have not received prior treatments in the advanced setting. It will also look at whether the effectiveness of the drug differs between TNBC adults with homologous recombination deficiency (HRD) subtypes and those with non-HRD subtypes. The main questions this study aims to answer are:

• Will patients with advanced TNBC who haven't received prior treatment in the advanced setting respond better (i.e., slowed disease progression) when given SG as a first-line treatment?
• Does the overall response rate of SG differ between HRD vs non-HRD advanced TNBC patients without prior treatment in the advanced setting? Participants will:
• Be given drug SG on days 1 and 8 of 21-day cycle(s)
• Will continue (repeat) 21-day cycles until disease progression or voluntary withdrawal
• Visit the clinic for treatments on days 1 and 8
• Have long-term follow-up every 12 weeks via phone or in-clinic

Conditions

Advanced Triple Negative Breast Cancer; Breast Cancer Metastatic; Breast Cancer

Keywords

advanced breast cancer; Sacituzumab govitecan; genomics; whole-genome and transcriptome analysis; triple negative breast cancer; Personalized OncoGenomics (POG)

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR) of SG in advanced TNBC

  To evaluate the overall response rate (ORR) of Sacituzumab govitecan (SG) in advanced triple-negative breast cancer (TNBC) patients without prior treatment in the advance setting, stratified by molecular subtypes using whole-genome and transcriptome analysis (WGTA).

  Up to an average of 6 months

• ORR of SG between HRD vs non-HRD in advanced TNBC

  2\. To compare the ORR of SG between homologous recombination-deficient (HRD) vs non-HRD advanced TNBC patients without prior treatment in the advance setting, utilizing WGTA.

  Up to an average of 6 months

Secondary Outcomes (4)

• Evaluate clinical benefit rate (CBR) of SG in advanced TNBC

  Up to an average of 6 months

• Assess progression-free survival (PFS) and overall-survival (OS) in advanced TNBC treated with SG

  Up to an average of 12 months

• Number of advanced TNBC participants receiving SG in first-line setting with treatment-related adverse events as assessed by CTCAE v5.0

  Up to an average of 3 months

• Changes in health-related quality of life when treated with SG

  At follow-up, within 30 days following the last dose of study drug

Study Arms (1)

Sacituzumab Govitecan

EXPERIMENTAL

Patients will receive SG at an initial dose of 10 mg per kilogram intravenously on day 1 and 8 of 21-day cycles. Treatment and cycles will continue until there is evidence of disease progression, significant toxicity, or if the participant or Investigator decide to discontinue treatment for any reason.

Drug: Sacituzumab Govitecan (SG)

Interventions

Sacituzumab Govitecan (SG) DRUG

Administer Sacituzumab Govitecan (SG) at 10 mg/kg as an intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. SG should not be administered as an IV push or bolus.

Also known as: Trodelvy

Sacituzumab Govitecan

Eligibility Criteria

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

You may qualify if:

• Participants must meet all the following criteria to be eligible for participation in this study:
• Willing and able to provide informed consent.
• Age \>18 years old at the time of informed consent and has signed informed consent before any trial related activities are conducted according to local guidelines.
• For participants of child-bearing potential (menstruation within \<2 years): negative serum pregnancy test within 14-days prior to enrollment and must be willing to use Health Canada-approved effective contraception methods (e.g., hormonal contraceptives, intrauterine device or system, tubal ligation, or double barrier method) starting 1 week prior to study treatment, throughout the study, and for 6 months following the last dose of SG.
• For participants considered not of child-bearing potential (postmenopausal): must meet one of the following criteria at the time of study entry:
• i. Prior bilateral oophorectomy ii. Age \> 60 iii. Age \< 60 with \>12 months of spontaneous amenorrhea (not due to chemotherapy, tamoxifen, toremifene, or ovarian suppression) and laboratory confirmation of postmenopausal FSH and estradiol levels per local postmenopausal reference ranges iv. Ovarian suppression with gonadotropin-releasing hormone (GnRH) agonist (e.g., goserelin) initiated \>28 days before Cycle 1 Day 1
• Advanced (locoregionally recurrent and non-operable, or metastatic) triple-negative breast cancer patients not amenable to curative therapy (surgery and/or radiotherapy), including those who are PDL1 negative (combined positive score \[cps\] \<10), immuno-oncology therapy ineligible, or who had early-relapse after neoadjuvant therapy and not eligible for immuno-oncology in the first-line setting.
• Histologically and/or cytologically confirmed diagnosis of estrogen-receptor negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).
• HER2-negative breast cancer (based on most recently analyzed biopsy) defined as negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, SISH) test is required by local laboratory testing, as defined in the relevant American Society of Clinical Oncology / College of American Pathologists Guidelines.
• Not previously received systemic therapy in the advanced setting.
• Participants can have measurable or non-measurable disease by CT or MRI as per RECIST Version 1.1 criteria as evaluated locally. Tumour lesions situated in a previously irradiated area are considered measurable if unequivocal progression has been documented in such lesions since radiation. All radiology studies must be performed within 28-days of Day 1 Cycle 1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Life expectancy \> 3 months.
• Acceptable bone marrow and organ function defined by the following laboratory values without transfusion or growth factor support within 2 weeks of treatment initiation:
• a. Absolute neutrophil count \> 1.0 x 109/L i. Platelets \> 100 x 109/L ii. Hemoglobin \> 90 g/dL iii. Potassium, sodium, calcium (corrected for serum albumin), and magnesium within normal limits.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Are within 4 weeks of participating in any other type of medical research judged by the Investigator to not be scientifically or medically compatible with this study.
• Tumour not accessible or not safe to perform biopsies.
• Has a known hypersensitivity to SG, irinotecan or its active metabolite SN-38.
• Has received prior antibody-drug conjugate containing a topoisomerase 1 inhibitor.
• Has a history of significant cardiovascular diseases, such as congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, serious cardiac arrhythmia, clinically significant electrocardiogram (ECG) findings or any other clinically significant cardiovascular condition, as determined by the Investigator.
• Has a history or evidence of any condition or laboratory abnormality that would place the participant at undue risk, as determined by the Investigator.
• Currently active Hepatitis B virus (HBV) or active Hepatitis C virus (HCV).
• For participants with a history of HBV infection, a hepatitis B core antibody test should be conducted at screening. If positive, hepatitis B DNA testing will be performed and if active HBV infection is ruled out, the participant may be eligible.
• Those who are HCV antibody positive with undetectable HCV viral load may be eligible.
• Has an active human immunodeficiency virus (HIV) infection (e.g., with detectable viral load).
• a. Participants positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
• Has not had resolution of all acute toxic effects of prior anti-cancer therapy to CTCAE version 5.0 grade \<1 (except toxicities not considered a safety risk for the participant at Investigator's discretion, e.g. grade 2 peripheral neuropathy from prior chemotherapy).
• Have an active second malignancy. Participants with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with surgically cured tumours with low risk of recurrence (e.g., non-melanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.
• Have known, untreated, active central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they have stable CNS disease, defined as no longer symptomatic from brain metastasis or no longer requires higher doses of corticosteroids (\>10mg Dexamethasone per day) for CNS symptom management. Anticonvulsants and stable corticosteroids dose can be included in the study. Screening for brain metastasis is not required for enrollment.

Sponsors & Collaborators

• British Columbia Cancer Agency: collaborator
• Nathalie Levasseur: lead

Study Sites (1)

BC Cancer - Vancouver Center

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (4)

• Goldenberg DM, Sharkey RM. Antibody-drug conjugates targeting TROP-2 and incorporating SN-38: A case study of anti-TROP-2 sacituzumab govitecan. MAbs. 2019 Aug/Sep;11(6):987-995. doi: 10.1080/19420862.2019.1632115. Epub 2019 Jul 18.

  PMID: 31208270 BACKGROUND

• Fenn KM, Kalinsky K. Sacituzumab govitecan: antibody-drug conjugate in triple-negative breast cancer and other solid tumors. Drugs Today (Barc). 2019 Sep;55(9):575-585. doi: 10.1358/dot.2019.55.9.3039669.

  PMID: 31584574 BACKGROUND

• Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortes J, O'Shaughnessy J, Dieras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485.

  PMID: 33882206 BACKGROUND

• Sukumar J, Gast K, Quiroga D, Lustberg M, Williams N. Triple-negative breast cancer: promising prognostic biomarkers currently in development. Expert Rev Anticancer Ther. 2021 Feb;21(2):135-148. doi: 10.1080/14737140.2021.1840984.

  PMID: 33198517 BACKGROUND

Related Links

• Sacituzumab govitecan (Trodelvy) Product Monograph

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dr. Nathalie LeVasseur, MD

CONTACT

604-877-6000; nathalie.levasseur@bccancer.bc.ca

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: Medical Oncologist, Principal Investigator

Model Details: This will be a non-randomized phase II single-arm study of first-line Sacituzumab govitecan in participants with advanced triple-negative breast cancer who have not received prior treatment in the advanced setting. Participants will receive an initial dose of SG on Days 1 and 8 of 21-day cycles. Treatment and cycles will continue until there is evidence of disease progression, significant toxicity, or if the participant or Investigator decide to discontinue treatment for any reason.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: December 23, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)