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New treatment option for Triple Negative Breast Cancer (TNBC)
Official title All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial
ClinicalTrials.gov ID: NCT06636981
What this study is testing
What is Cohort2: ATRA+Toripalimab+TPC?
Cohort2: ATRA+Toripalimab+TPC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple negative breast cancer (tnbc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- All trans retinoic acid Combined with Toripalimab+Chemotherapy for Locally Advanced inoperable or Metastatic Triple Negative Breast Cancer：a multi-center, multi-cohort phase II trial
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- The people voluntarily participate and sign a written informed consent form;
- Age ≥ 18 years old;
- For locally advanced inoperable or metastatic breast cancer confirmed by histology (according to AJCC 8th edition staging), the histology and...
- According to RECIST 1.1 criteria for solid tumor evaluation, there must be at least one measurable lesion;
- Cohort 1: For locally advanced non operable or metastatic TNBC that has not been previously treated, intravenous chemotherapy and anti-tumor therapy...
You likely can't join if
- Individuals who have previously been treated with PD-1 or PD-L1 monoclonal antibodies; Participants in cohort 1 who have previously used albumin...
- Individuals known to be allergic to any of the drugs in the study;
- Patients who have hypersensitivity reactions to other vitamin A drugs;
- History of active autoimmune diseases requiring systemic treatment in the past 2 years (e.g. corticosteroids (dose ≤ 10mg/day, except for prednisone...
- Diagnosed with immune deficiency or undergoing systemic steroid therapy (excluding doses ≤ 10mg/day of prednisone or other effective hormones) or any...
- There are other known malignant tumors that have progressed or require active treatment in the past 5 years. Excluding malignant tumors that can be...
See the full eligibility criteria
- The people voluntarily participate and sign a written informed consent form;
- Age ≥ 18 years old;
- For locally advanced inoperable or metastatic breast cancer confirmed by histology (according to AJCC 8th edition staging), the histology and pathology clearly showed that ER, PR, Her-2 were negative. If there was...
- According to RECIST 1.1 criteria for solid tumor evaluation, there must be at least one measurable lesion;
- Cohort 1: For locally advanced non operable or metastatic TNBC that has not been previously treated, intravenous chemotherapy and anti-tumor therapy may be used during previous neoadjuvant and/or adjuvant therapy...
- All people should undergo tumor lesion biopsy during the screening period to obtain sufficient qualified tumor tissue specimens for retrospective biomarker analysis (including PD-L1 expression levels) in their cohort...
- The main organ function is good, the relevant examination indicators within 14 days before treatment meet the following requirements: Without blood transfusion, platelet count ≥ 100 × 10\^9/L, hemoglobin ≥ 90g/L...
- Expected survival period ≥ 3 months;
- ECOG PS score: 0-1 points;
- Non surgical sterilization, male patients with women of childbearing age or partners of childbearing age, are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill...
- Individuals who have previously been treated with PD-1 or PD-L1 monoclonal antibodies; Participants in cohort 1 who have previously used albumin paclitaxel;
- Individuals known to be allergic to any of the drugs in the study;
- Patients who have hypersensitivity reactions to other vitamin A drugs;
- History of active autoimmune diseases requiring systemic treatment in the past 2 years (e.g. corticosteroids (dose ≤ 10mg/day, except for prednisone or other effective hormones) or immunosuppressive drugs);
- Diagnosed with immune deficiency or undergoing systemic steroid therapy (excluding doses ≤ 10mg/day of prednisone or other effective hormones) or any other form of immunosuppressive therapy within 7 days prior to...
- There are other known malignant tumors that have progressed or require active treatment in the past 5 years. Excluding malignant tumors that can be treated locally and have already been cured, such as skin basal cell...
- Known to have active central nervous system (CNS) metastases;
- History of non infectious pneumonia requiring steroid hormone therapy;
- Active infections require systematic treatment;
- There are serious uncontrolled hypertension, diabetes and hyperlipidemia;
- History of II-IV congestive heart failure or myocardial infarction within 6 months prior to enrollment;
- Individuals who tested positive for HIV during screening;
- Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV copy number\>upper limit of normal value);
- Individuals with other serious acute or chronic physiological or mental problems;
- Accepting any medication that is prohibited from being used in combination with the investigational drug, unless the medication has been discontinued within 7 days prior to enrollment;
- Lactating women;
- Individuals who have participated in clinical trials of other anti-tumor drugs within the past four weeks;
- Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption;
- Any situation that other researchers consider unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.