Actively Recruiting
HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan
Led by SOLTI Breast Cancer Research Group · Updated on 2024-07-19
50
Participants Needed
10
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study-specific procedures
- Male or female patients aged 18 years or older
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed locally advanced or metastatic breast cancer not amenable to curative surgery or radiation
- Hormone receptor-positive, HER2-negative breast cancer by local testing
- Disease refractory to CDK4/6 inhibitors as defined by specified recurrence or progression timelines
- No more than one prior chemotherapy or antibody-drug conjugate regimen for metastatic disease
- Radiologic or objective evidence of disease progression on or after last systemic therapy
- Measurable or evaluable disease according to RECIST v1.1
- Presence of disease site amenable to safe biopsy
- Ability to perform biopsy before treatment, after 2 weeks of treatment, and at end of treatment on the same lesion
- Tumor tissue of adequate quality for central laboratory evaluation
- Normal organ and bone marrow function within 35 days prior to treatment, including specified lab value thresholds
- Life expectancy of at least 16 weeks
- Agreement to use protocol-specified contraception methods if of childbearing potential
- Willingness and ability to comply with study requirements and restrictions
You will not qualify if you...
- HER2-positive or triple-negative breast cancer
- Other malignancies unless curatively treated with no evidence of disease for at least 3 years, with specified exceptions
- Unresolved toxicities from previous anticancer therapy above grade 1, except certain stable chronic toxicities
- Participation in another investigational study within 2 weeks or 5 half-lives prior to enrollment
- Symptomatic uncontrolled brain metastases or unstable CNS disease
- Significant cardiovascular disease including severe heart failure or recent myocardial infarction
- Active chronic inflammatory bowel disease or recent gastrointestinal perforation
- Active serious infections requiring IV antibiotics, antivirals, or antifungals
- Known HIV infection
- Active hepatitis B or C infection
- Other medical or psychiatric conditions interfering with study participation
- Receipt of live vaccine within 30 days prior to randomization
- Prior treatment with sacituzumab govitecan
- Known severe allergy to sacituzumab govitecan or its components
- Requirement for prohibited medications as listed in the protocol
- Positive pregnancy test or lactating women
AI-Screening
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Trial Site Locations
Total: 10 locations
1
ICO Badalona
Badalona, Barcelona, Spain, 08916
Not Yet Recruiting
2
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Not Yet Recruiting
3
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Not Yet Recruiting
4
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
5
HU Clínico San Cecilio
Granada, Spain, 18016
Not Yet Recruiting
6
Fundación Jiménez Díaz
Madrid, Spain, 28040
Not Yet Recruiting
7
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Not Yet Recruiting
8
Hospital Sant Joan de Reus
Reus, Spain, 43204
Actively Recruiting
9
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Not Yet Recruiting
10
Hospital Clínico de Valencia
Valencia, Spain, 46010
Not Yet Recruiting
Research Team
M
Mariana Paes Dias, PhD
CONTACT
F
Fernando Salvador, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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