HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan

NCT06236269 | Recruiting Phase 2

• 1 other identifier: SOLTI-2201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

Brief Summary

This is an open-label, single arm, non-randomized, multicenter phase II study for the identification of predictive biomarkers of sacituzumab govitecan benefit and the understanding of key resistance mechanisms in HR+/HER2- advanced/metastatic breast cancer patients

Conditions

Breast Cancer Stage IV

Keywords

sacituzumab govitecan; breast cancer; CelTIL

Outcome Measures

Primary Outcomes (1)

• CelTIL score

  Mean change in CelTIL score per central assessment between paired tumor samples in the overall population. CelTIL score = -0.8 x tumor cellularity (%) + 1.3 x tumor-infiltrating lymphocytes (TILs) (%). The minimum and maximum unscaled CelTIL scores will be -80 and 130. This unscaled CelTIL score will then be scaled to reflect a range from 0 to 100 points.

  baseline and at Cycle 2 Day 1 (14-21 days after treatment initiation)

Secondary Outcomes (15)

• Overall Response rate (ORR)

  Until objective tumor response, assessed up to approximately 9 months

• Clinical Benefit Rate (CBR)

  Until objective tumor response, assessed up to approximately 9 months

• Progression free survival (PFS)

  From date of enrollment to disease progression or death from any cause,whichever came first, assessed up to approximately 9 months

• Duration of response (DoR)

  From date of enrollment to disease progression or death from any cause,whichever came first, assessed up to approximately 9 months

• Time to response (TtR)

  Until objective tumor response, assessed up to approximately 9 months

Study Arms (1)

Sacituzumab Govitecan

EXPERIMENTAL

Sacituzumab govitecan will be given on Days 1, 8 of a 21-day cycle at a dose of 10 mg/kg intravenously, continuously until progression of the disease or unacceptable toxicity.

Drug: Sacituzumab Govitecan

Interventions

Sacituzumab Govitecan DRUG

Sacituzumab Govitecan 10 mg/kg will be administrad intravenously (IV) on Days 1, 8 of a 21-day cycle

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:

• Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
• Patients must be male or female (pre/peri or postmenopausal) ≥ 18 years of age.
• ECOG performance status of 0 or 1(see Appendix 1).
• Histologically or cytologically confirmed breast cancer with evidence of locally advanced disease, not amenable to resection or radiation therapy with curative intent or metastatic disease.
• HR+/HER2- BC by local testing, not amenable to surgical therapy will be enrolled in this study.
• HER2 negativity is defined as either of the following by local laboratory assessment: IHC 0, IHC 1+ or IHC2+/in situ hybridization (ISH) negative as per the most recent American Society of Clinical Oncology (ASCO)-College of American Pathologists Guideline (CAP) guideline. If a patient has had multiple HER2 results after metastatic disease, the most recent test result prior screening period will be used to confirm eligibility.
• ER and/or PR positivity are defined as \>1% of cells expressing HR via IHC analysis as per most recent ASCO-CAP guideline. If a patient has had multiple ER/PgR results after metastatic disease, the most recent test result prior screening period will be used to confirm eligibility.
• Disease refractory to CDK4/6 inhibitors, defined as recurrence during or within 12 months after the end of adjuvant treatment or progression during or within 6 months after the end of treatment for advanced/metastatic disease.
• No more than 1 prior systemic chemotherapy or antibody-drug conjugate (ADC) regimens for metastatic disease. Adjuvant or neoadjuvant therapy for early-stage disease will qualify as one of the required prior chemotherapy regimens if the development of unresectable, locally advanced, or metastatic disease occurred within a 12-month period of time of the therapy. Note: treatments for bone metastases (eg, bisphosphonates, denosumab, etc.), targeted therapies (eg, PARP inhibitors, CDK 4/6 inhibitors, immunotherapy etc.) and hormonal therapy are not considered as prior systemic chemotherapy treatments for advanced disease.
• Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting study treatment
• Measurable or non-measurable disease but evaluable (identification of target and/or non-target lesions by RECIST Vs1.1).
• Patients must have a site of disease amenable to safely perform a biopsy, as per Investigator's assessment, and be a candidate for tumor biopsy according to the treating institution's guidelines.
• Acceptable samples include core needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, bone or mucosal lesions or biopsies from bone metastases. Lymph node biopsies are also permitted.
• Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable.
• Patients must have normal organ and bone marrow function measured within 35 days prior to administration of study treatment as defined below:

You may not qualify if:

• Patients with HER2-positive or TNBC disease.
• Other malignancy unless curatively treated with no evidence of disease for ≥3 years except: non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma or other malignant tumors with an expected curative outcome after medical monitor approval.
• Has unresolved toxicities from previous anticancer therapy (≥ CTCAE version 5.0 grade 1) caused by previous cancer therapy, excluding alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to ≥Grade 2 for at least 2 months prior to enrollment and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as: Chemotherapy-induced neuropathy, Fatigue, Residual toxicities from prior IO treatment Grade 1 or Grade 2 endocrinopathies. Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Patients may not be participating in a study with an investigational agent or investigational device within 2 weeks or 5 half-lives, whichever is longer, prior to allocation. Patients participating in observational studies are eligible.
• Patients with symptomatic uncontrolled brain metastases. Participants with a history of treated Central Nervous System (CNS) metastases are eligible, provided they meet all of the following criteria:
• Biopsiable disease outside the CNS is present.
• No evidence of interim CNS progression between the completion of CNS directed therapy and the screening radiographic study.
• Metastases are limited solely to cerebellar and supratentorial lesions.
• Stable requirement for corticosteroids (≤ 20 mg oral prednisone or equivalent) or anticonvulsants during \>4 weeks as therapy for CNS disease.
• No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to enrolment.
• No evidence of progression or haemorrhage after completion of CNS directed therapy.
• Patients with spinal cord compression are excluded unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
• History of significant cardiovascular disease, defined as:
• New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction of \< 40%.
• Unstable angina or myocardial infarction within 6 months before enrolment.

Sponsors & Collaborators

• SOLTI Breast Cancer Research Group: lead

Study Sites (10)

ICO Badalona

Badalona, Barcelona, 08916, Spain

NOT YET RECRUITING

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

NOT YET RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

HU Clínico San Cecilio

Granada, 18016, Spain

NOT YET RECRUITING

Fundación Jiménez Díaz

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

NOT YET RECRUITING

Hospital Sant Joan de Reus

Reus, 43204, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

NOT YET RECRUITING

Hospital Clínico de Valencia

Valencia, 46010, Spain

NOT YET RECRUITING

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

• Eva Ciruelos, MD

  Hospital 12 de Octubre, Madrid/SOLTI

  PRINCIPAL INVESTIGATOR

• Mafalda Oliveira, MD

  Hospital Vall d'Hebrón/SOLTI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana Paes Dias, PhD

CONTACT

0034 609 384 751; mariana.paes@gruposolti.org

Fernando Salvador, PhD

CONTACT

0034 616 194 478; fernando.salvador@gruposolti.org

Study Design

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

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 1, 2024
• Study Start: March 15, 2024
• Primary Completion: February 20, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: July 19, 2024

Record last verified: 2023-12

Locations

ES (10)