Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer

NCT07367178 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: MEDOPP8242025-524109-33-00
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) or hormone receptor-positive/HER2-negative (HR(+)/HER2-) treated with sacituzumab govitecan.

Conditions

Breast Cancer; Advanced HR+/HER2- Breast Cancer; Advanced Triple-Negative Breast Cancer

Keywords

Advanced TNBC; Sacituzumab govitecan; Atropine; Tolerance; Advanced HR+/HER2-; Prophylaxis; SATROPIN

Outcome Measures

Primary Outcomes (1)

• To assess the incidence and severity of diarrhea during the first two treatment cycles

  Incidence of grade ≥2 diarrhea during the first two treatment cycles as assessed by the Investigator, with severity determined by the NCI-CTCAE v.6.0.

  Baseline up to end of 2nd cycle (day 42)

Secondary Outcomes (11)

• To assess the incidence and severity of constipation during the first two treatment cycles

  Baseline up to end of 2nd cycle (day 42)

• To determine the overall safety profile during the first two treatment cycles and the extended follow-up.

  Until EoS (9 months after last participant is included in the Study unless premature termination of the Study)

• To evaluate the incidence and severity of diarrhea during the first two treatment cycles versus extended follow-up.

  Until EoS (9 months after last participant is included in the Study unless premature termination of the Study)

• To evaluate the incidence and severity of constipation during the first two treatment cycles versus extended follow-up.

  Until EoS (9 months after last participant is included in the Study unless premature termination of the Study)

• To assess the dose reduction rate.

  Until EoS (9 months after last participant is included in the Study unless premature termination of the Study)

Study Arms (1)

Sacituzumab govitecan + Atropine + G-CSF

EXPERIMENTAL

After having confirmed eligibility and enrollment into the clinical trial, participants will receive sacituzumab govitecan at a dose of 10 mg/kg body weight, administered via intravenous (IV) infusion on Day 1 and Day 8 of each 21-day cycle. Subcutaneous atropine sulfate at a dose of 0.5 mg will be given as premedication prior to each sacituzumab govitecan infusion during the first two treatment cycles. Continuation of atropine beyond Cycle 2 will be at the discretion of the Investigator. Participants will be treated until unacceptable toxicity, disease progression, withdrawal of consent, death, or study termination, whichever occurs first. To improve hematologic tolerability, G-CSF will be used as a supportive medication during the first 2 cycles of sacituzumab govitecan. The use of G-CSF beyond the second cycle will be at the discretion of the Investigator.

Drug: Sacituzumab Govitecan (SG); Drug: Atropine; Drug: G-CSF (Granulocyte colony-stimulating factor)

Interventions

Sacituzumab Govitecan (SG) DRUG

Participants will receive sacituzumab govitecan at a dose of 10 mg/kg body weight, administered via intravenous (IV) infusion on Day 1 and Day 8 of each 21-day cycle until unacceptable toxicity, disease progression, death, discontinuation from the Study treatment for any other reason or End of the Study (EoS), whichever occurs first.

Also known as: Trodelvy

Sacituzumab govitecan + Atropine + G-CSF

Atropine DRUG

Participants will receive atropine at a dose of 0.5 mg as premedication 10 minutes before prior to each sacituzumab govitecan infusion during the first two treatment cycles. Continuation of atropine beyond Cycle 2 will be at the discretion of the Investigator.

Sacituzumab govitecan + Atropine + G-CSF

G-CSF (Granulocyte colony-stimulating factor) DRUG

All participants will receive 0.5MU/kg/day of G-CSF, according to the participant's weight, which will be administered subcutaneously (SC), once a day during two consecutive days, 48 hours after administration of sacituzumab govitecan (D3, D4 and D10, D11) during the first two cycles. The use of G-CSF beyond the second treatment cycle will be at the discretion of the Investigator.

Also known as: Filgrastim, non-PEGylated G-CSF

Sacituzumab govitecan + Atropine + G-CSF

Eligibility Criteria

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

You may qualify if:

• Participant, or legal representative (if applicable), must be capable of understanding the purpose of the Study and have signed a written informed consent form (ICF) prior to beginning specific protocol procedures.
• Female or male participants ≥ 18 years of age at the time of signing ICF.
• ECOG performance status of 0 or 1.
• Minimum life expectancy of ≥ 12 weeks at screening.
• Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to curative therapy.
• For TNBC participants only:
• i. Histologically confirmed TNBC of the most recent available sample per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 criteria on the most recently analyzed biopsy. TNBC status is defined as \<1% expression for estrogen receptor (ER) and progesterone receptor (PgR) and negative for human epidermal growth factor receptor 2 (HER2) (0-1+ by immunohistochemistry \[IHC\] or 2+ and negative by in situ hybridization \[ISH\] test).
• For HR(+)/HER2(-) breast cancer participants only:
• i. Histologically confirmed HR(+)/HER2(-) breast cancer of the most recent available sample per ASCO/CAP 2018 criteria on the most recently analyzed biopsy. HR(+)/HER2(-) status is defined as ≥1% expression for ER and/or PgR and negative for HER2 (0-1+ by IHC or 2+ and negative by ISH test).
• ii. Disease progression to at least one prior endocrine therapy for advanced disease.
• iii. Disease progression to previous CDK4/6i-based therapy in any setting. For participants who received CDK4/6i in the adjuvant setting, a minimum of one year of treatment and a disease-free interval (DFI) of ≤12 months are required.
• Note: For participants with ER-low positive tumor (defined as ER expression between 1% and 10%) previous therapy with CDK4/6 inhibitors and/or endocrine therapy is permitted but not required.
• Disease progression to no more than two prior standard of care chemotherapy-based regimens for advanced disease (prior ADC will count as a chemotherapy-based regimen).
• Note: Earlier adjuvant or neoadjuvant therapy for early breast cancer will be considered as one of the required prior regimens if the development of unresectable locally advanced or metastatic disease occurred within a 12-month period after treatment completion.
• Prior treatment with a trophoblast cell-surface antigen 2 (TROP2) ADC and/or topoisomerase I inhibitor or an ADC containing a topoisomerase I inhibitor is only allowed in the (neo)adjuvant setting if the development of unresectable locally advanced or metastatic disease occurred at least 12 months after treatment completion.

You may not qualify if:

• Participation in another clinical trial, interventional or observational, until the Study's safety visit.
• Note: Participation in retrospective studies or data analysis is allowed.
• Known leptomeningeal disease or active uncontrolled or symptomatic central nervous system (CNS) metastases as indicated by clinical symptoms, and/or progressive growth are excluded.
• Note: Participants with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before the first dose of Study treatment.
• Have a concurrent malignancy or malignancy within three years of Study enrollment with the exception of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.
• Known allergy or hypersensitivity reaction to any investigational medicinal product(s) (IMP\[s\]) or its (their) incorporated substances.
• Participants at risk of urinary retention (e.g.,those with prostatic hypertrophy), prior history of glaucoma, both open and closed angle, and previous diagnosis of myasthenia gravis, conditions in which atropine is contraindicated.
• Requirement for ongoing therapy with any prohibited medications listed in the protocol.
• Have received prior radiotherapy within two weeks before the first dose of Study treatment (four weeks in case of radiation therapy of the central nervous system). Participants must have recovered from all radiation-related toxicities, not require steroids.
• Major surgical procedure or significant traumatic injury within 14 days before the first dose of Study treatment or anticipation of need for major surgery within the course of the Study treatment.
• Known history of unstable angina, myocardial infarction, or cardiac heart failure present within six months of study initiation or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy or history of QT interval prolongation.
• Clinically significant active pulmonary compromise at screening (e.g., ongoing infection, uncontrolled COPD/asthma exacerbation).
• Note: Participants with stable chronic lung diseases (e.g., controlled COPD, asthma, bronchiectasis, post-COVID fibrosis) may be enrolled but atropine should be used with caution and participants should be monitored for respiratory complications.
• Known history of clinically significant bleeding, thrombosis, intestinal obstruction, or gastrointestinal perforation within six months of study initiation.
• Documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in baseline grade ≥1 diarrhea).

Sponsors & Collaborators

• MedSIR: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sacituzumab govitecan; Atropine; Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

MEDSIR

CONTACT

+34 932 214 135; contact.trials@medsir.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: International, multicenter, open-label, single-arm, phase II clinical trial.

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share