Breast Cancer Stage IVPhase 2ACROSS-TROP2NCT06236269
HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan
A Phase 2 study testing Sacituzumab Govitecan in people with Breast Cancer Stage IV, run by SOLTI Breast Cancer Research Group at 10 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Stage IV
- What is being tested?
- Sacituzumab Govitecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesSpain
- Study dates
- 15 Mar 2024to 20 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Possibility of performing a biopsy prior to the start of treatment and its repetition after 2 weeks (14-21 days) and at End of Treatment (EOT) on the same location. It will be provided formalin-fixed paraffin-embedded (FFPE) tumor block. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to enrollment. Patients whose tumor tissue is not evaluable for central testing are not eligible. It is recommended to send the biopsy directly to the central lab after confirming the existence of a tumor, so as not to delay the inclusion, without the need to carry out IHC studies in the same sample.
- 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:
- Haemoglobin ≥ 9.0 g/dL *
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L*
- Platelet count ≥ 100 x 109/L*
- Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia).
- AST (SGOT) / ALT (SGPT) ≤ 2.5 x ULN unless liver metastases are present in which case, they must be ≤ 5x ULN
- Creatinine ≤ 1.5 x ULN or Creatinine clearance estimated of ≥30mL/min using the Cockcroft-Gault equation.
- Serum albumin >3 g/dL
- International normalized ratio (INR) or prothrombin time (PT) and either partial thromboplastin or activated partial thromboplastin time (aPTT) ≤ 1.5 ×ULN *Without transfusional or growth factor support within 1 week of study treatment initiation.
- Patients must have a life expectancy ≥ 16 weeks.
- Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 2.
- Willing and able to comply with the requirements and restrictions in this protocol.
Who cannot join
- 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.
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- 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.
- History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.
- Have active serious infection requiring requiring IV antibiotics, antivirals, or antifungals.
- Have a known history of Human Immunodeficiency Virus (HIV).
- Have active HBV (defined as having a positive HbsAg test) or HCV.
- For patients 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 patient may be eligible.
- Patients who are HCV antibody positive with polymerase chain reaction negative for HCV RNA may be eligible.
- Have 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.
- Has received a live vaccine within 30 days prior to randomization.
- Prior treatment with Sacituzumab-govitecan.
- Known or severe (≥ Grade 3) hypersensitivity or allergy to sacituzumab govitecan, their metabolites, or formulation excipient.
- Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 7.5.
- Positive serum pregnancy test or women who are lactating (see Appendix 2).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Spain10 sites, 10 recruiting
- Not yet recruiting
ICO Badalona
Badalona, Barcelona, 08916
Angelica Ferrando, MD
- Not yet recruiting
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Mafalda Oliveira, MD
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Tomás Pascoal, MD
- Not yet recruiting
HU Clínico San Cecilio
Granada, 18016
Isabel Blancas, MD
- Not yet recruiting
ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08907
Rafael Villanueva, MD
- Not yet recruiting
Fundación Jiménez Díaz
Madrid, 28040
Yann Izarzugaza, MD
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Eva Ciruelos, MD
- Recruiting
Hospital Sant Joan de Reus
Reus, 43204
Kepa Amillano, MD
- Not yet recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
Javier Salvador Bofil, MD
- Not yet recruiting
Hospital Clínico de Valencia
Valencia, 46010
Juan M Cejalvo, MD
About this study
Official title: Prospective Biomarker Analysis in HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan
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
Read the detailed description
This study will include patients with HR+/HER2- advanced/metastatic breast cancer who have progressed on prior endocrine therapy and CDK4/6i and who have received up to 1 prior regimen of chemotherapy or ADC for metastatic breast canncer.
The primary objective is to evaluate the change in the CelTIL score, a combined biomarker based on stromal tumor-infiltrating lymphocytes and tumor cellularity, as surrogate of treatment response after one dose of sacituzumab govitecan (SG).
Patients who fulfil all eligibility criteria will start SG at 10 mg/kg as an IV infusion on Days 1 and 8 of a 21-day cycle. SG will be administered continuously until progression of the disease, unacceptable toxicity, investigator's decision, withdrawal of consent, or other reasons described in the protocol.
Tumor tissue (newly obtained) will be sent to a central laboratory. After 2 weeks(14-21 days) of treatment a new biopsy of the same lesion will be performed. Tumor biopsy will be also performed at disease progression / EoT. In addition, blood samples (for ctDNA) will be collected at C1D1, C2D1 and at progression / EoT for exploratory objectives.
Imaging will be performed prior to day 1 of treatment and target and non-target lesions will be identified as per RECIST 1.1. Tumor assessments will be performed every 9 weeks until the start of a new anti-cancer therapy, withdrawal of consent, progression of disease, death, or the end of the study, whichever occurs first. Tumor assessments will be performed on the specified schedule regardless of treatment delays. Tumor response will be assessed as per RECIST v.1.1.
Safety assessments will include the incidence, nature, and severity of AEs and laboratory abnormalities graded per the NCI CTCAE v.5.0. Laboratory safety assessments will include the regular monitoring of hematology, blood chemistry and pregnancy test.
- Conditions
- Breast Cancer Stage IV
- Being tested
- Sacituzumab Govitecan
- Keywords
- sacituzumab govitecan, breast cancer, CelTIL
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab GovitecanDrug
Also called Trodelvy
Sacituzumab Govitecan 10 mg/kg will be administrad intravenously (IV) on Days 1, 8 of a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sacituzumab Govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and at Cycle 2 Day 1 (14-21 days after treatment initiation)
Secondary outcomes (15)
Overall Response rate (ORR)
proportion of patients with measurable disease with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Measured: Until objective tumor response, assessed up to approximately 9 months
Clinical Benefit Rate (CBR)
Proportion of patients with a best overall response of CR, PR or an overall lesion response of Stable Disease (SD) or Non- PR/Non-progression disease (PD) lasting ≥24 weeks, based on local investigator´s assessment according to RECIST v1.1.
Measured: Until objective tumor response, assessed up to approximately 9 months
Progression free survival (PFS)
Time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurs first.
Measured: 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)
Time from the first occurrence of a documented objective response to disease progression, as determined locally by the investigator through use of RECIST v.1.1, or death from any cause, whichever occurs first.
Measured: 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)
Time from enrollment to the first objective tumor response (tumor shrinkage of ≥30%) observed for patients who achieved a CR or PR.
Measured: Until objective tumor response, assessed up to approximately 9 months
Correlation between baseline TROP2 expression and the variation of CelTIL score
Correlation between TROP2 mRNA baseline levels and changes in CelTIL score at C2D1.
Measured: Baseline and at the start of Cycle 2 (Day 1, cycle of 21 days)
Correlation between TROP2 mRNA expression with TROP2 IHC expression
Correlation coefficients between TROP2 mRNA and TROP2 IHC biomarkers.
Measured: Baseline
Correlation between baseline TROP2 IHC expression with changes in CelTIL score
Correlation between TROP2 IHC baseline levels and changes in CelTIL score at C2D1
Measured: Baseline and at the start of Cycle 2 (Day 1, cycle of 21 days)
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Association of TROP2 mRNA expression \& TROP2 IHC expression at baseline with ORR.
Measured: Until objective tumor response, assessed up to approximately 9 months
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Association of TROP2 mRNA expression \& TROP2 IHC expression at baseline with CBR.
Measured: Until objective tumor response, assessed up to approximately 9 months
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Association of TROP2 mRNA expression \& TROP2 IHC expression at baseline with PFS.
Measured: Until objective tumor response, assessed up to approximately 9 months
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Association of TROP2 mRNA expression \& TROP2 IHC expression at baseline with DoR.
Measured: Until objective tumor response, assessed up to approximately 9 months
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Association of TROP2 mRNA expression \& TROP2 IHC expression at baseline with TtR.
Measured: Until objective tumor response, assessed up to approximately 9 months
Correlation of CelTIL score at C2D1 with long-term outcome
Correlation of CelTIL score at C2D1 with ORR, CBR, PFS, DoR, TtR
Measured: Until objective tumor response, assessed up to approximately 9 months
Assess safety and tolerability of Sacituzumab Govitecan
Incidence, seriousness, treatment-related and severity (grade) of Treatment Emergent Adverse Events (TEAEs) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5, including dose reductions, delays and treatment discontinuations.
Measured: Through study completion, from date of enrollment to end of study, assessed up to approximately 29 months after the first patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start15 Mar 2024
- Primary completion20 Feb 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Ciruelos, MD, Principal investigator, Hospital 12 de Octubre, Madrid/SOLTIMafalda Oliveira, MD, Principal investigator, Hospital Vall d'Hebrón/SOLTI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236269
- Sponsor's protocol ID
- SOLTI-2201
- Acronym
- ACROSS-TROP2
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Biomarker Analysis in HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan
- ClinicalTrials.gov ID
- NCT06236269
- Acronym / sponsor ID
- ACROSS-TROP2 / SOLTI-2201
- Conditions
- Breast Cancer Stage IV
- Keywords
- sacituzumab govitecan, breast cancer, CelTIL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SOLTI Breast Cancer Research GroupUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study will include patients with HR+/HER2- advanced/metastatic breast cancer who have progressed on prior endocrine therapy and CDK4/6i and who have received up to 1 prior regimen of chemotherapy or ADC for metastatic breast canncer.
The primary objective is to evaluate the change in the CelTIL score, a combined biomarker based on stromal tumor-infiltrating lymphocytes and tumor cellularity, as surrogate of treatment response after one dose of sacituzumab govitecan (SG).
Patients who fulfil all eligibility criteria will start SG at 10 mg/kg as an IV infusion on Days 1 and 8 of a 21-day cycle. SG will be administered continuously until progression of the disease, unacceptable toxicity, investigator's decision, withdrawal of consent, or other reasons described in the protocol.
Tumor tissue (newly obtained) will be sent to a central laboratory. After 2 weeks(14-21 days) of treatment a new biopsy of the same lesion will be performed. Tumor biopsy will be also performed at disease progression / EoT. In addition, blood samples (for ctDNA) will be collected at C1D1, C2D1 and at progression / EoT for exploratory objectives.
Imaging will be performed prior to day 1 of treatment and target and non-target lesions will be identified as per RECIST 1.1. Tumor assessments will be performed every 9 weeks until the start of a new anti-cancer therapy, withdrawal of consent, progression of disease, death, or the end of the study, whichever occurs first. Tumor assessments will be performed on the specified schedule regardless of treatment delays. Tumor response will be assessed as per RECIST v.1.1.
Safety assessments will include the incidence, nature, and severity of AEs and laboratory abnormalities graded per the NCI CTCAE v.5.0. Laboratory safety assessments will include the regular monitoring of hematology, blood chemistry and pregnancy test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan | Experimental | Drug: Sacituzumab GovitecanSacituzumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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.
Key exclusion criteria (28 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab GovitecanAlso: TrodelvySacituzumab Govitecan 10 mg/kg will be administrad intravenously (IV) on Days 1, 8 of a 21-day cycle | Drug | Sacituzumab Govitecan |
Primary outcome
CelTIL score
Time frame: baseline and at Cycle 2 Day 1 (14-21 days after treatment initiation)
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.
15 secondary outcomes
Overall Response rate (ORR)
Time frame: Until objective tumor response, assessed up to approximately 9 months
Clinical Benefit Rate (CBR)
Time frame: Until objective tumor response, assessed up to approximately 9 months
Progression free survival (PFS)
Time frame: 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)
Time frame: 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)
Time frame: Until objective tumor response, assessed up to approximately 9 months
Correlation between baseline TROP2 expression and the variation of CelTIL score
Time frame: Baseline and at the start of Cycle 2 (Day 1, cycle of 21 days)
Correlation between TROP2 mRNA expression with TROP2 IHC expression
Time frame: Baseline
Correlation between baseline TROP2 IHC expression with changes in CelTIL score
Time frame: Baseline and at the start of Cycle 2 (Day 1, cycle of 21 days)
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Time frame: Until objective tumor response, assessed up to approximately 9 months
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Time frame: Until objective tumor response, assessed up to approximately 9 months
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Time frame: Until objective tumor response, assessed up to approximately 9 months
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Time frame: Until objective tumor response, assessed up to approximately 9 months
Clinical benefit according to TROP2 mRNA expression & TROP2 IHC expression at baseline.
Time frame: Until objective tumor response, assessed up to approximately 9 months
Correlation of CelTIL score at C2D1 with long-term outcome
Time frame: Until objective tumor response, assessed up to approximately 9 months
Assess safety and tolerability of Sacituzumab Govitecan
Time frame: Through study completion, from date of enrollment to end of study, assessed up to approximately 29 months after the first patient enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Ciruelos, MD principal investigator
Hospital 12 de Octubre, Madrid/SOLTI
Mafalda Oliveira, MD principal investigator
Hospital Vall d'Hebrón/SOLTI
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Govitecan in people with Breast Cancer Stage IV, run by SOLTI Breast Cancer Research Group at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Paes Dias, PhD (0034 609 384 751, mariana.paes@gruposolti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CelTIL score (time frame: baseline and at Cycle 2 Day 1 (14-21 days after treatment initiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.