Breast Cancer MetastaticPhase 2NCT05420779
A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in Breast Cancer Patients With Germline BRCA Mutations
A Phase 2 study testing TSL-1502 capsules(low dose), TSL-1502 capsules(high dose) and Investigator's choice of chemotherapy in people with Breast Cancer Metastatic, run by Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This research study is evaluating the efficacy and safety of TSL-1502 capsules in patients with breast cancer, will be included HER2-negative locally advanced or metastatic breast cancer patients with germline BRCA mutations. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- TSL-1502 capsules(low dose), TSL-1502 capsules(high dose) and Investigator's choice of chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Agree to follow the clinical trial protocol, volunteer, and sign the informed consent form (ICF).
- 2) Women aged ≥ 18 years and ≤ 75 years at the date of signing the ICF. 3) HER2-locally advanced breast cancer diagnosed by histopathology and/or cytology (Unable to receive radical therapy) or metastatic breast cancer, and previous chemotherapeutic line of cytotoxicity for locally advanced or metastatic breast cancer was ≤ 3.
- 4) Prior platinum therapy is allowed, but the best response to platinum therapy is required to be CR, PR, or persistent ≥ 12 weeks SD. If given as neoadjuvant/adjuvant therapy, the time from the last dose of platinum to relapse is ≥ 6 months.
- 5) Hormone receptor-positive patients need to have received at least first-line of endocrine therapy for locally advanced or metastatic breast cancer but failed, or unsuitable for endocrine therapy in the judgment of the investigator.
- 6) In neoadjuvant, adjuvant and/or metastatic stages, the patients who have received antitumor therapy with Taxane ± Anthracycline.
- 7) Failure of front-line therapy (disease progression or toxicity intolerance), and the investigator judged that it was suitable to receive the systemic monotherapy (including capecitabine tablets, vinorelbine tartrate injection, eribulin mesylate injection).
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- 8) Tested or reviewed by a third-party central laboratory to determine whether there is harmful or suspected harmful gBBRCAm in the blood.
- 9) At least one measurable (non-lymph node longest diameter ≥ 10 mm, lymph nodes with a minimum diameter of ≥ 15 mm, according to RECIST version 1.1 criteria) of target lesions. Note: Previously irradiated lesions cannot be used as targets lesions unless there is significant progression of the lesion.
- 10) The physical condition score is 0-1 according to the scale of The Eastern Cooperative Oncology Group (ECOG).
- 11) Expected survival ≥ 12 weeks. 12) Meet the following criteria (The use of any blood components and cell growth factors is not permitted within 2 weeks prior to initial administration): Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); platelets ≥ 100 × 109/L (1 × 105/mm3); Hemoglobin ≥ 90 g/L; Liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN), but except for Gilbert's syndrome patients (persistent or recurrent hyperbilirubinemia, unbound bilirubin elevation is present in the absence of evidence of hemolysis or liver pathology); patients without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; ALT and AST ≤ 5×ULN for patients with liver metastasis; Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 50 mL/min (Calculated according to the Cockcroft-Gault formula); Cockcroft-Gault formula: female Ccr (mL/min) = 0.85 × weight (kg) × (140-age)/ [72 × creatinine (mg/dL)] Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- 13) Women of childbearing age are willing to take effective contraception from signing the ICF to 6 months after the last administration of the investigational drug. Women of childbearing age must have a negative blood pregnancy test result 7 days before the first dose.
Who cannot join
- 1) Pregnant or lactating women. 2) Active inflammatory breast cancer. 3) Previous treatment with other PARP inhibitor drugs, including but not limited to TSL-1502, Olaparib, Talazoparil, Fluzoparil, Nilaparib, Rucaparib, Veliparib, etc. 4) Known to be allergic to TSL-1502 or any excipient of TSL-1502 capsules. 5) Known to have active brain metastases (defined as meeting any of the following: stable neurological imaging < 4 weeks; symptoms related to brain metastasis; steroid therapy required; leptomeningeal disease); patients must have completed any prior treatment for brain metastases ≥ 4 weeks prior to the first dose.
- 6) Patients with previous or current another malignancy. 7) Have other serious or uncontrollable clinical diseases or past medical history, surgical history, including but not limited to hepatic/renal dysfunction, respiratory disorders, endocrine disorders, metabolic disorders, neuropathy, or mental disorders, organ transplantation, etc.
- 8) Gastrointestinal or digestive system diseases that may affect the absorption of investigational products as judged by the investigator or past medical history, such as intractable hiccups, nausea, vomiting, chronic gastrointestinal disease (e.g. Ron's disease, ulcerative colitis, active gastric ulcer, etc.), dysphagia, etc.
- 9) Have serious cardiovascular system disease or past medical history (meet any of the following conditions); Definite cardiovascular abnormality within 6 months prior to first dose (e.g., myocardial infarction, cardiac arrhythmia, angina pectoris, angioplasty, vascular stent implantation, coronary artery bypass surgery, congestive heart failure, etc.); Baseline electrocardiogram QT or Fridericia-corrected QT interval (QTcF) prolongation [QTcF = QT/(RR 0.33), QTcF > 480 ms]; Left ventricular ejection fraction < 50% by cardiac ultrasound; Uncontrolled hypertension (Patients with blood pressure ≥150/100 mmHg after lifestyle improvement and medication) 10) Participated in clinical trials of other drugs or medical devices within 4 weeks prior to initial administration (note: except for those who did not use investigational drugs or medical devices).
- 11) Patients who underwent major surgery or significant traumatic injury within 4 weeks prior to initial administration, or who planned to undergo major surgery in the trial period.
- 12) Chemotherapy, radiotherapy, non-hormone targeted therapy, endocrine therapy, Anti-neoplastic immunotherapy [physiologic replacement doses of corticosteroids permitted (prednisone or equivalent < 15 mg/day)], Chinese medicine therapy with a clear indication for the treatment of breast cancer, or other anti-tumor therapy were received within 4 weeks prior to initial administration.
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- 13) AEs related to previous surgery and previous anti-tumor therapy (CTCAE version 5.0) did not recover to ≤ 1 grade (alopecia, pigmentation, platinum-induced neurotoxicity grade 2 and lower, except for clinically significant or asymptomatic laboratory abnormalities).
- 14) Patients who had received a CYP2D6 liver enzyme inhibitors or inducers within 2 weeks prior to initial dosing, or who cannot discontinue the use of CYP2D6 liver enzyme inhibitors or inducers during the trial.
- 15) Patients who test positive for treponema pallidum antibody, human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) RNA, or active hepatitis B patients [defined as hepatitis B virus (HBV) DNA ≥ ULN].
- 16) The investigator considered that patients have other conditions that might affect compliance or are not suitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Binghe Xu, 13501028690, bhxu@hotmail.com
About this study
Official title: A Randomized, Parallel, Open-label, Positive Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in HER2-negative Locally Advanced or Metastatic Breast Cancer Patients With Germline BRCA Mutations
This research study is evaluating the efficacy and safety of TSL-1502 capsules in patients with breast cancer, will be included HER2-negative locally advanced or metastatic breast cancer patients with germline BRCA mutations.
Read the detailed description
Background:
Breast cancer is a collective term for a variety of malignant breast tumors.According to the World Cancer Report newly released by the World Health Organization in February 2020, breast cancer ranks first in the causes of death among women due to cancer worldwide, with about 2.1 million new cases and 627,000 deaths in 2018. At present, the main treatments for breast cancer are surgery, chemotherapy, and endocrine therapy, but the therapeutic effect is limited. The 5-year survival rate for patients with advanced breast cancer is only 20%, and the overall survival (OS) is 2 ~ 3 years.
Research basis:
Tumor cells can activate their own DNA repair machinery to repair DNA damage caused by drugs and thus become resistant to radiotherapy and chemotherapy, while there is overexpression of DNA repair enzymes in a variety of tumor cells. Therefore, reducing the expression of DNA repair enzymes or inhibiting their activity may exert latent anti-tumor effects.
Specific aims:
To evaluate the objective response rate at least 4 weeks later,disease control rate,duration of response,progression-free survival and objective response rate and overall survival in patients withHER2-negative locally advanced or metastatic breast cancer patients with germline BRCA mutations. Also we plan to estimate safety endpoints and PK endpoints in this subject population.
Treatment plan:
Patients will be randomized in three arms. In arm A , patients will be treated with low dose TSL-1502 capsules, 350 mg each time, orally administered QD, every 3 weeks as a treatment cycle. In arm B , patients will be treated with the same interference with high dose,500 mg each time, orally administered QD, every 3 weeks as a treatment cycle. In arm B , patients will be treated with investigator's choice of chemotherapy.
- Conditions
- Breast Cancer Metastatic
- Being tested
- TSL-1502 capsules(low dose), TSL-1502 capsules(high dose), Investigator's choice of chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSL-1502 capsules(low dose)Drug
350 mg each time, orally administered QD, every 3 weeks as a treatment cycle.
TSL-1502 capsules(high dose)Drug
500 mg each time, orally administered QD, every 3 weeks as a treatment cycle.
Investigator's choice of chemotherapyDrug
Capecitabine tablets, 1250 mg/m2 each time, BID oral administration; Vinorelbine tartrate injection, 25 ~ 30 mg/m2 each time, intravenous drip (15 ~ 20 min); Eribulin mesylate injection, 1.4 mg/m2 each time, intravenous injection (2 ~ 5 min)
| Study group | Role | What they receive |
|---|---|---|
| TSL-1502 low dose group | Experimental | TSL-1502 capsules 350 mg,qd,po Receives: Drug: TSL-1502 capsules(low dose) |
| TSL-1502 high dose group | Experimental | TSL-1502 capsules 500 mg,qd,po Receives: Drug: TSL-1502 capsules(high dose) |
| Positive control group | Active comparator | Investigator selects chemotherapy regimens according to the subjects' conditions. Receives: Drug: Investigator's choice of chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
Defined as the proportion of patients with complete response (CR) and partial response (PR). Solid tumors evaluation criteria (RECIST) version 1.1 is used for anti-tumor efficacy evaluation. For patients with PR or CR at the first evaluation, response confirmation should be performed at least 4 weeks later
Measured: Radiological scans performed at baseline then every 6 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 40 months
Secondary outcomes (6)
Disease Control Rate(DCR)
DCR is defined as the proportion of patients with CR, PR and stable disease (SD).
Measured: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
Duration of Response(DOR)
DOR is defined as the time from the first assessment of CR or PR to disease progression or death due to any cause.
Measured: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
Progress Free Survival(PFS)
PFS is defined as the time from randomization to the first disease progression or death due to any cause, whichever occurs first. 12 Months PFS Rate is defined as the percentage of subjects without disease progression or death from any cause 12 months after the beginning of randomization or the probability estimated by Kaplan-Meier method.
Measured: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
Overall Survival(OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
12 Months PFS Rate
12 Months PFS Rate is defined as the percentage of subjects without disease progression or death from any cause 12 months after the beginning of randomization or the probability estimated by Kaplan-Meier method.
Measured: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
Safety endpoints
all AEs and SAEs by CTCAE v5.0
Measured: From screening until final visit.Assessed up to a maximum of 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start30 Jun 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rui Liu, Study director, Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420779
- Sponsor's protocol ID
- TSL-CM-TSL1502-Ⅱ
- Status last verified
- May 2024
- First submitted
- 22 May 2022
- Last updated
- 8 May 2024
- Results posted
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Open-label, Positive Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in HER2-negative Locally Advanced or Metastatic Breast Cancer Patients With Germline BRCA Mutations
- ClinicalTrials.gov ID
- NCT05420779
- Acronym / sponsor ID
- TSL-CM-TSL1502-Ⅱ
- Conditions
- Breast Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Jun 2022 (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.
This research study is evaluating the efficacy and safety of TSL-1502 capsules in patients with breast cancer, will be included HER2-negative locally advanced or metastatic breast cancer patients with germline BRCA mutations.
Detailed description
Background:
Breast cancer is a collective term for a variety of malignant breast tumors.According to the World Cancer Report newly released by the World Health Organization in February 2020, breast cancer ranks first in the causes of death among women due to cancer worldwide, with about 2.1 million new cases and 627,000 deaths in 2018. At present, the main treatments for breast cancer are surgery, chemotherapy, and endocrine therapy, but the therapeutic effect is limited. The 5-year survival rate for patients with advanced breast cancer is only 20%, and the overall survival (OS) is 2 ~ 3 years.
Research basis:
Tumor cells can activate their own DNA repair machinery to repair DNA damage caused by drugs and thus become resistant to radiotherapy and chemotherapy, while there is overexpression of DNA repair enzymes in a variety of tumor cells. Therefore, reducing the expression of DNA repair enzymes or inhibiting their activity may exert latent anti-tumor effects.
Specific aims:
To evaluate the objective response rate at least 4 weeks later,disease control rate,duration of response,progression-free survival and objective response rate and overall survival in patients withHER2-negative locally advanced or metastatic breast cancer patients with germline BRCA mutations. Also we plan to estimate safety endpoints and PK endpoints in this subject population.
Treatment plan:
Patients will be randomized in three arms. In arm A , patients will be treated with low dose TSL-1502 capsules, 350 mg each time, orally administered QD, every 3 weeks as a treatment cycle. In arm B , patients will be treated with the same interference with high dose,500 mg each time, orally administered QD, every 3 weeks as a treatment cycle. In arm B , patients will be treated with investigator's choice of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TSL-1502 low dose group | Experimental | Drug: TSL-1502 capsules(low dose)TSL-1502 capsules 350 mg,qd,po |
| TSL-1502 high dose group | Experimental | Drug: TSL-1502 capsules(high dose)TSL-1502 capsules 500 mg,qd,po |
| Positive control group | Active comparator | Drug: Investigator's choice of chemotherapyInvestigator selects chemotherapy regimens according to the subjects' conditions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1) Agree to follow the clinical trial protocol, volunteer, and sign the informed consent form (ICF).
- 2) Women aged ≥ 18 years and ≤ 75 years at the date of signing the ICF. 3) HER2-locally advanced breast cancer diagnosed by histopathology and/or cytology (Unable to receive radical therapy) or metastatic breast cancer, and previous chemotherapeutic line of cytotoxicity for locally advanced or metastatic breast cancer was ≤ 3.
- 4) Prior platinum therapy is allowed, but the best response to platinum therapy is required to be CR, PR, or persistent ≥ 12 weeks SD. If given as neoadjuvant/adjuvant therapy, the time from the last dose of platinum to relapse is ≥ 6 months.
- 5) Hormone receptor-positive patients need to have received at least first-line of endocrine therapy for locally advanced or metastatic breast cancer but failed, or unsuitable for endocrine therapy in the judgment of the investigator.
- 6) In neoadjuvant, adjuvant and/or metastatic stages, the patients who have received antitumor therapy with Taxane ± Anthracycline.
Key exclusion criteria (10 listed)
- 1) Pregnant or lactating women. 2) Active inflammatory breast cancer. 3) Previous treatment with other PARP inhibitor drugs, including but not limited to TSL-1502, Olaparib, Talazoparil, Fluzoparil, Nilaparib, Rucaparib, Veliparib, etc. 4) Known to be allergic to TSL-1502 or any excipient of TSL-1502 capsules. 5) Known to have active brain metastases (defined as meeting any of the following: stable neurological imaging < 4 weeks; symptoms related to brain metastasis; steroid therapy required; leptomeningeal disease); patients must have completed any prior treatment for brain metastases ≥ 4 weeks prior to the first dose.
- 6) Patients with previous or current another malignancy. 7) Have other serious or uncontrollable clinical diseases or past medical history, surgical history, including but not limited to hepatic/renal dysfunction, respiratory disorders, endocrine disorders, metabolic disorders, neuropathy, or mental disorders, organ transplantation, etc.
- 8) Gastrointestinal or digestive system diseases that may affect the absorption of investigational products as judged by the investigator or past medical history, such as intractable hiccups, nausea, vomiting, chronic gastrointestinal disease (e.g. Ron's disease, ulcerative colitis, active gastric ulcer, etc.), dysphagia, etc.
- 9) Have serious cardiovascular system disease or past medical history (meet any of the following conditions); Definite cardiovascular abnormality within 6 months prior to first dose (e.g., myocardial infarction, cardiac arrhythmia, angina pectoris, angioplasty, vascular stent implantation, coronary artery bypass surgery, congestive heart failure, etc.); Baseline electrocardiogram QT or Fridericia-corrected QT interval (QTcF) prolongation [QTcF = QT/(RR 0.33), QTcF > 480 ms]; Left ventricular ejection fraction < 50% by cardiac ultrasound; Uncontrolled hypertension (Patients with blood pressure ≥150/100 mmHg after lifestyle improvement and medication) 10) Participated in clinical trials of other drugs or medical devices within 4 weeks prior to initial administration (note: except for those who did not use investigational drugs or medical devices).
- 11) Patients who underwent major surgery or significant traumatic injury within 4 weeks prior to initial administration, or who planned to undergo major surgery in the trial period.
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 |
|---|---|---|
| TSL-1502 capsules(low dose)350 mg each time, orally administered QD, every 3 weeks as a treatment cycle. | Drug | TSL-1502 low dose group |
| TSL-1502 capsules(high dose)500 mg each time, orally administered QD, every 3 weeks as a treatment cycle. | Drug | TSL-1502 high dose group |
| Investigator's choice of chemotherapyCapecitabine tablets, 1250 mg/m2 each time, BID oral administration; Vinorelbine tartrate injection, 25 ~ 30 mg/m2 each time, intravenous drip (15 ~ 20 min); Eribulin mesylate injection, 1.4 mg/m2 each time, intravenous injection (2 ~ 5 min) | Drug | Positive control group |
Primary outcome
Objective response rate(ORR)
Time frame: Radiological scans performed at baseline then every 6 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 40 months
Defined as the proportion of patients with complete response (CR) and partial response (PR). Solid tumors evaluation criteria (RECIST) version 1.1 is used for anti-tumor efficacy evaluation. For patients with PR or CR at the first evaluation, response confirmation should be performed at least 4 weeks later
6 secondary outcomes
Disease Control Rate(DCR)
Time frame: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
Duration of Response(DOR)
Time frame: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
Progress Free Survival(PFS)
Time frame: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
Overall Survival(OS)
Time frame: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
12 Months PFS Rate
Time frame: Radiological scans performed at baseline then every 6 weeks there after until disease progression or death due to any cause.Assessed up to a maximum of 40 months
Safety endpoints
Time frame: From screening until final visit.Assessed up to a maximum of 40 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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. This study is not recruiting at the moment.
Rui Liu study director
Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TSL-1502 capsules(low dose), TSL-1502 capsules(high dose) and Investigator's choice of chemotherapy in people with Breast Cancer Metastatic, run by Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. at 1 site 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 10 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Liu (02286343626, liurui2@tasly.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: Radiological scans performed at baseline then every 6 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 40 months). 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 8 May 2024.