Clinical trial NCT05928780: An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC in First-line Treatment (FUTURE-Trop2)
Official title: A Molecular Pathway-based Umbrella Trial for First-line Precision Therapy With TROP2 in Patients With Locally Advanced or Metastatic TNBC (Future-Trop2 Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: TNBC - Triple-Negative Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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).
* No peripheral neuropathy or grade I peripheral neurotoxicity.
* Fertile female subjects are required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug; The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.

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);
* Participated in clinical trials of other antitumor drugs within 4 weeks before taking the study drug for the first time;
* long-term unhealed wounds or incomplete healing fractures;
* Patients with known HBV or HCV infection active phase or hepatitis B DNA≥500, or chronic phase with abnormal liver function;
* Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
* Malignant tumors within the past five years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).

Primary outcomes:
measure: PFS
timeFrame: max 6 months
Secondary outcomes:
measure: OS
timeFrame: max 6 months
measure: ORR
timeFrame: max 6 months
measure: DOR
timeFrame: max 6 months
Other outcomes:
Locations:
Study officials:
References: