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An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2) | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2)

A Molecular Pathway-based Umbrella Trial for First-line Precision Therapy With TROP2 in Patients With Locally Advanced or Metastatic TNBC (Future-Trop2 Study)

NCT05928780•Fudan University

View on ClinicalTrials.gov

Summary

To explore the efficacy and safety of TROP2 in the treatment of ABC

Detailed Description

To explore the efficacy and safety of advanced first-line TROP2 precision therapy in patients with locally advanced or metastatic triple-negative breast cancer based on molecular subtypes

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Women ≥18 years old and ≤70 years old.
•ECOG body status level 0 \~ 1.
•The expected survival is not less than 3 months.
•Breast cancer patients with histologically proven invasive triple-negative breast cancer (specifically defined as estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) who are all negative by pathological tests. Specifically: ER negative: IHC\<1%, PR negative: IHC\<1%, HER2 negative: IHC-/+ or IHC++ but FISH/CISH negative. All specimens should be verified by the pathology department of the research center, and the molecular typing of relapses and metastases should be re-checked.
•Tumor stage: recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible.
•Stage II: patients who have not used paclitaxel or have used paclitaxel in adjuvant/neoadjuvant therapy, but the interval from the end of treatment to relapse is greater than 6 months; No systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has been received in the advanced stage.
•Stage I: The advanced stage has received ≥1 line systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.).
•Have at least one measurable lesion or unmeasurable lesion according to RECIST version 1.1 (measurable lesion ≥20mm conventional CT scan and ≥10mm spiral CT scan, measurable lesion not receiving radiotherapy).
•The functions of the main organs are basically normal.
•Have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery (except for procedures unrelated to antitumor therapy such as central venous catheterization) within 3 weeks prior to the start of the study, and have recovered from acute toxic effects of previous treatment (if surgery is available, the wound has fully healed).
+2 more criteria

Exclusion Criteria

•Stage II: patients with adjuvant/neoadjuvant use of paclitaxel but the interval from the end of taxol treatment to recurrence and metastasis is less than 6 months, or have received systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) in the late stage;
•Stage I: no systemic anti-tumor therapy (chemotherapy, targeted therapy, etc.) has been received in the advanced stage;
•Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastasis, enhanced CT or enhanced Magnetic Resonance Imaging (MRI) must be performed within 28 days before the first dose to rule out central nervous system metastasis.
•A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
•Persistent grade ≥1 adverse events due to previous treatment. The exception to this is hair loss or something the researchers believe should not be ruled out. Such cases should be clearly documented in the investigator's notes;
•Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access);
•Pregnant or lactating patients;
•Other malignancies within the previous 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma.
•Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect drug use and absorption;
•There is a third space effusion that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites);
+5 more criteria

Key Dates

Start Date

July 1, 2023

Primary Completion Date

March 1, 2024

Completion Date

September 1, 2025

Last Updated

July 3, 2023

Enrollment

125

ESTIMATED participants

Conditions

TNBC - Triple-Negative Breast Cancer

Interventions

A1:SG with SHR3680

DRUG

A2:SG

DRUG

B1:SG with SHR1210

DRUG

B2:SG

DRUG

C1:SG with SHR3162

DRUG

C2:SG

DRUG

D1:SG with VEGFRI

DRUG

D2:SG

DRUG

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

NCT05914961

TNBC - Triple-Negative Breast Cancer

View study

RECRUITINGPHASE1/PHASE2

Study of AVZO-021 in Patients With Advanced Solid Tumors

NCT05867251

Advanced Solid TumorHR+/HER2- Breast Cancer+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2)

Inclusion Criteria

Exclusion Criteria

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

Study of AVZO-021 in Patients With Advanced Solid Tumors

BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia

Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK

Trop-2 Targeted PET Probes in Advanced TNBC

A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer