Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping（(A Phase II, Open-label, Single-center Platform Study）

Plain English Summary

FUSCC Refractory TNBC Platform Study (FUTURE2.0) is a Phase 2 clinical trial sponsored by Fudan University studying Triple-negative Breast Cancer. This study tests new drug combinations for women with triple-negative breast cancer that has stopped responding to other treatments. It is for women aged 18 and older with advanced or returning triple-negative breast cancer that has spread and is no longer treatable with standard therapies. Participants will receive one of several investigational drug treatments, and their progress will be closely monitored. Alternative treatments may include other chemotherapy, targeted therapies, or immunotherapy, depending on the patient's specific situation and prior treatments. The trial aims to enroll 120 participants.

Official Summary

This is a Phase II, open-label, Single-center platform study research based on molecular subtypes to explore precision therapy in refractory triple-negative breast cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18 or older with a confirmed diagnosis of triple-negative breast cancer. Must have advanced or metastatic cancer that has progressed after at least one prior treatment. Must have measurable disease and generally good organ function. Cannot have active brain metastases or significant heart problems. This trial is studying Triple-negative Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well the new treatments shrink tumors, which indicates their effectiveness in controlling the cancer. The specific primary outcome measures are: Overall response rate (ORR) (Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for new treatments for triple-negative breast cancer, a particularly aggressive form of the disease that often recurs or spreads and has limited treatment options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Triple-negative Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in breast cancer, with potential for novel therapies to capture a share of the growing oncology market, though approval probability depends on robust effica Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if your specific type of triple-negative breast cancer might benefit from these new treatments. Understand that participation involves regular clinic visits for drug administration, monitoring, and tests. Be prepared for potential side effects and the need for close communication with the study team. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 120 participants

Interventions

• DRUG: A1: SHR-A1811 — A1: an anti-HER2 antibody-drug conjugate (ADC)
• DRUG: A2: SHR-A1811 with Camrelizumab with famitinib — A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC) Camrelizumab: an anti-programmed death-1 (PD-1) antibody
• DRUG: B1: TROP2 ADC — B1: an Trophoblast cell-surface antigen 2 (TROP2) ADC
• DRUG: B2: TROP2 ADC with Camrelizumab — B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC Camrelizumab: an anti-programmed death-1 (PD-1) antibody
• DRUG: C1: SHR-A1811 — C1: an anti-HER2 antibody-drug conjugate (ADC)

Primary Outcomes

• Overall response rate (ORR) (Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years))

Secondary Outcomes

• Progression Free Survival (PFS) (Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years))
• Duration of Response (DoR) (Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study(approximately 3 years))
• Disease Control Rate (DCR) (Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study(approximately 3 years))
• Overall Survival (OS) (Randomization to death from any cause, through the end of study (approximately 3 years))
• CTCAE scale (V5.0) (Up to One Year during follow-up)

Full Eligibility Criteria

Inclusion Criteria:

1. Female aged ≥18 years;
2. TNBC invasive breast cancer confirmed by histology (specific definition: ER \<1% positive tumor cells by immunohistochemistry are defined as ER negative, PR \<1% positive tumor cells are defined as PR negative, HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negative); Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
3. Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC
4. At least one measurable lesion according to RECIST 1.1 (conventional CT scan ≥20 mm, spiral CT scan ≥10 mm, measurable lesion has not received radiotherapy);
5. The functions of the main organs are basically normal and meet the following conditions:

   i. Blood routine examination criteria shall meet: HB ≥90 g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 10\^9 /L; PLT acuity 75 x 10\^9 /L;

   ii. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
6. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity;
7. ECOG score ≤1, and life expectancy ≥3 months;
8. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;
9. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

1. Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);
2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
3. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;
4. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;
5. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
6. Pregnant or lactating patients;
7. Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.

Trial Locations

• Fudan University Shanghai Cancer Center, Shanghai, China

Frequently Asked Questions

Related Conditions

• Triple-negative breast cancer
• Metastatic breast cancer
• Advanced breast cancer
• Hormone receptor-negative breast cancer
• HER2-negative breast cancer
• Breast cancer recurrence
• Oncology
• Cancer immunotherapy
• Targeted cancer therapy
• Antibody-drug conjugates

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