Triple Negative Breast Cancer (TNBC)Phase 2NCT06636981
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
A Phase 2 study testing Cohort2: ATRA+Toripalimab+TPC and Cohort1: ATRA+Toripalimab+chemo in people with Triple Negative Breast Cancer (TNBC), run by Fudan University at 2 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Cohort2: ATRA+Toripalimab+TPC and Cohort1: ATRA+Toripalimab+chemo
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 2 sitesChina
- Study dates
- 4 Nov 2024to Sep 2029
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects 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 metastatic lesion pathology, the metastatic lesion histology and pathology should prevail. The definition of ER and PR negativity is: IHC ER\<1%, IHC PR\<1%. Her-2 negativity is defined as: immunohistochemical detection of Her-2 (-) or (1+), Her-2 (2+) must undergo FISH testing and the result is negative, Her-2 (-) or (1+) can choose to undergo FISH testing and the result is negative;
- 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 stages, provided that the interval between the end of neoadjuvant and/or adjuvant therapy and the occurrence of recurrence/metastasis is ≥ 12 months; Cohort 2: Local late stage inoperable or metastatic TNBC with previous treatment failures of at least one line or above;
- All subjects 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. If subjects are unable to undergo biopsy, they should provide tumor samples or unstained sections (3-5 μm) that have been fixed in formalin and embedded in paraffin (FFPE) closest to the start of the study treatment (up to 24 months) for corresponding biomarker analysis;
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- 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, neutrophil count (ANC) ≥ 1.5 × 10^9/L AST and ALT ≤ 2.5 x upper limit of normal (ULN), ≤ 5 x ULN if liver metastasis is present, total bilirubin ≤ 1.5 x ULN, serum creatinine (Cr) ≤ 1.5 ULN, or creatinine clearance rate ≥ 60mL/min (Cockcroft Gault formula)
- 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, or condom) during the study treatment period and within 6 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum HCG test within 72 hours prior to enrollment in the study.
Who cannot join
- 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 enrollment;
- 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 carcinoma, skin squamous cell carcinoma, and cervical cancer in situ;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Hongxia wang, PHD, 02164175590, whx365@126.com
hongxia wang, PHD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
About this study
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
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Being tested
- Cohort2: ATRA+Toripalimab+TPC, Cohort1: ATRA+Toripalimab+chemo
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort2: ATRA+Toripalimab+TPCDrug
Receive 200 mg D1 of Toripalimab via intravenous infusion for a course of 21 days; TPC regimen (monoclonal antibody 10mg/kg D1, 8 intravenous infusions, 1 course of treatment every 21 days; Elibulin 1.4mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Utideron 40mg/m2 D1-5 intravenous infusions, 1 course of treatment every 21 days; Gemcitabine 1000mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Albumin paclitaxel 100 mg/m2 D1, D8, intravenous infusion, 1 course of treatment every 21 days); Capecitabine 1000mg/m2, D1-14, oral, one course of treatment every 21 days); All trans retinoic acid 20 mg bid, orally, D-3-D11, administered continuously for 14 days, stopped for 7 days, with one course of treatment lasting 21 days.
Cohort1: ATRA+Toripalimab+chemoDrug
Receive 200 mg of Toripalimab via D1 intravenous infusion, with 21 days as one course of treatment; Albumin paclitaxel 100 mg/m2, D1, D8, intravenous infusion, one course of treatment for 21 days; All trans retinoic acid 20 mg bid, oral, D-3-D11, continuous administration for 14 days, cessation for 7 days, 21 days is one course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| cohort1: All trans retinoic acid+Toripalimab+Chemotherapy | Experimental | Not described Receives: Drug: Cohort1: ATRA+Toripalimab+chemo |
| cohort2: ATRA+Toripalimab+TPC | Experimental | Not described Receives: Drug: Cohort2: ATRA+Toripalimab+TPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
During the combined therapy, tumor assessment (enhanced CT) is conducted every 3 cycles (6 weeks), and the efficacy is evaluated using the RECIST 1.1 criteria. ORR will be summarized as the proportion of subjects achieving objective tumor responses (complete response or partial response). ORR and its 95% confidence interval will be calculated.
Measured: up to 2 years
Secondary outcomes (6)
Overall Survival (OS)
Overall survival (OS) will be defined as time from initiation of therapy to death, or censored at last follow-up date if the Patient is alive and will be calculated based on modified RECIST version 1.1 and iRECIST. Kaplan-Meier methods will be used to estimate OS with 95% CI.
Measured: up to 2 years
Progression-Free Survival (PFS)
Progression free survival (PFS) will be defined as the time from initiation of therapy to the time of RECIST progression or death and will be calculated based on modified RECIST version 1.1 and iRECIST. Kaplan-Meier methods will be used to estimate PFS with 95% CI.
Measured: up to 2 years
Duration of Response (DOR)
DOR is defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis will be censored at the date of their last tumor assessment. Per RECIST 1.1
Measured: up to 2 years
Adverse events
Adverse events and toxicity will be assessed according to the NCI-CTCAE 5.0 criteria. Medical review of adverse events and laboratory values will be conducted, and a safety assessment will be completed. Safety assessments will be conducted for all subjects receiving the study drug, with evaluation starting from the date of informed consent signing and continuing until the study concludes or 30 days after drug discontinuation.
Measured: up to 2 years
Skin adverse reactions
Incidence of hand foot syndrome,, maculopapular rash, itching, urticaria, and pigmentation Skin rash and erythema NCI CTCAE level severity Dermatology Quality of Life Questionnaire (DLQI)
Measured: up to 2 years
Biomarker analysis
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start4 Nov 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636981
- Sponsor's protocol ID
- TNBC-ATRA-IIT-001
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- TNBC-ATRA-IIT-001
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Oct 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohort1: All trans retinoic acid+Toripalimab+Chemotherapy | Experimental | Drug: Cohort1: ATRA+Toripalimab+chemo |
| cohort2: ATRA+Toripalimab+TPC | Experimental | Drug: Cohort2: ATRA+Toripalimab+TPC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subjects 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 metastatic lesion pathology, the metastatic lesion histology and pathology should prevail. The definition of ER and PR negativity is: IHC ER\<1%, IHC PR\<1%. Her-2 negativity is defined as: immunohistochemical detection of Her-2 (-) or (1+), Her-2 (2+) must undergo FISH testing and the result is negative, Her-2 (-) or (1+) can choose to undergo FISH testing and the result is negative;
- 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 stages, provided that the interval between the end of neoadjuvant and/or adjuvant therapy and the occurrence of recurrence/metastasis is ≥ 12 months; Cohort 2: Local late stage inoperable or metastatic TNBC with previous treatment failures of at least one line or above;
Key exclusion criteria (19 listed)
- 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 enrollment;
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 |
|---|---|---|
| Cohort2: ATRA+Toripalimab+TPCReceive 200 mg D1 of Toripalimab via intravenous infusion for a course of 21 days; TPC regimen (monoclonal antibody 10mg/kg D1, 8 intravenous infusions, 1 course of treatment every 21 days; Elibulin 1.4mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Utideron 40mg/m2 D1-5 intravenous infusions, 1 course of treatment every 21 days; Gemcitabine 1000mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Albumin paclitaxel 100 mg/m2 D1, D8, intravenous infusion, 1 course of treatment every 21 days); Capecitabine 1000mg/m2, D1-14, oral, one course of treatment every 21 days); All trans retinoic acid 20 mg bid, orally, D-3-D11, administered continuously for 14 days, stopped for 7 days, with one course of treatment lasting 21 days. | Drug | cohort2: ATRA+Toripalimab+TPC |
| Cohort1: ATRA+Toripalimab+chemoReceive 200 mg of Toripalimab via D1 intravenous infusion, with 21 days as one course of treatment; Albumin paclitaxel 100 mg/m2, D1, D8, intravenous infusion, one course of treatment for 21 days; All trans retinoic acid 20 mg bid, oral, D-3-D11, continuous administration for 14 days, cessation for 7 days, 21 days is one course of treatment. | Drug | cohort1: All trans retinoic acid+Toripalimab+Chemotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 2 years
During the combined therapy, tumor assessment (enhanced CT) is conducted every 3 cycles (6 weeks), and the efficacy is evaluated using the RECIST 1.1 criteria. ORR will be summarized as the proportion of subjects achieving objective tumor responses (complete response or partial response). ORR and its 95% confidence interval will be calculated.
6 secondary outcomes
Overall Survival (OS)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Adverse events
Time frame: up to 2 years
Skin adverse reactions
Time frame: up to 2 years
Biomarker analysis
Time frame: up to 2 years
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 13 Dec 2024.
- Individual participant dataSharing planned: No
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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.
2 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 Cohort2: ATRA+Toripalimab+TPC and Cohort1: ATRA+Toripalimab+chemo in people with Triple Negative Breast Cancer (TNBC), run by Fudan University at 2 sites in China.
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 11 inclusion and 19 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Zhonghua Tao, MD (86 13774315805, drtaozhh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 2 years). 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 13 Dec 2024.