Advanced Breast CancerPhase 2NCT06339281
A Multicenter Clinical Study of Apatinib Mesylate Combined With Doctor's Choice for Advanced Breast Cancer
A Phase 2 study testing apatinib mesylate+Capecitabine Tablets and apatinib mesylate+Fulvestrant injection in people with Advanced Breast Cancer, run by Li Huiping.
Trial summary
Previous studies have found good efficacy of (investigator's choice of chemotherapy, or endocrine drug) in combination with apatinib mesylate in the treatment of her-2 negative, chest wall metastatic advanced breast cancer, and the present study proposes to further explore the efficacy of apatinib mesylate in her-2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- apatinib mesylate+Capecitabine Tablets and apatinib mesylate+Fulvestrant injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to Dec 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed her-2 negative, HR-positive progressive breast cancer (prior chemotherapy (including adjuvant or neoadjuvant) with anthracycline and/or paclitaxel required);
- No more than 3 lines of chemotherapy for recurrent or metastatic breast cancer;
- Must have progression previously used endocrine therapy and CDK4/6 inhibitors for recurrent or metastatic disease ;
- PET-CT（SUV）>5;
- Age ≥18 years;
- ECOG PS 0-1;
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- life expectancy ≥ 3 months
- Have at least one measurable lesion as a target lesion confirmed by CT or MRI according to RECIST version 1.1 criteria. If the target lesion is a lymph node require a short diameter greater than 1.5 ，and the target lesion is not amenable to surgical treatment; the target lesion has not received radiotherapy or has recurred in the radiotherapy field;
- Appropriate hematopoiesis；
- Appropriate liver function；
- Appropriate renal function；
- Normal coagulation;
- Females of childbearing potential willing to use contraception during the trial: negative serum or urine pregnancy test within 7 days prior to dosing.
Who cannot join
- Received radiation therapy within 28 days prior to enrollment. Radiotherapy for the relief of metastatic bone pain prior to enrollment is permitted, provided that no more than 30% of the total marrow-containing bone is irradiated, with the exception of patients with good bone feel prior to treatment;
- The presence of evidence of central nervous system metastases;
- Current or recent (within 30 days prior to enrollment) use of another investigational drug or participation in another clinical study
- Other malignancy within 5 years (except adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or controlled basal cell carcinoma of the skin)
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacologic therapy)
- Myocardial ischemia or myocardial infarction of class II or greater, poorly controlled arrhythmias (including qtc intervals ≥450 ms in men and ≥470 ms in women);
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- Grade III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound suggesting left ventricular ejection fraction (LVEF) <50%;
- Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or under thrombolytic or anticoagulant therapy;
- Have had clinically significant bleeding symptoms or a definite bleeding tendency within the previous 3 months, such as gastrointestinal bleeding, bleeding gastric ulcer, fecal occult blood +++ or more at baseline, or have vasculitis
- Have undergone major surgical procedures or have sustained a severe traumatic injury, fracture, or ulcer within the previous 4 weeks
- Having factors that significantly affect the absorption of oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction, etc;
- Urine routine suggestive of urinary protein ≥ ++, or confirmed 24-hour urine protein volume ≥ 1.0 g;
- Plasmapheresis (including pleural fluid, ascites, and pericardial effusion) that is clinically symptomatic and requires surgical management;
- Other conditions that, in the judgment of the investigator, may affect the conduct of the clinical study and the determination of the study results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Clinical Study of Apatinib Mesylate in Combination With a Physician's Choice Regimen for Her-2 Negative, HR-positive Progressive Breast Cancer.
Previous studies have found good efficacy of (investigator's choice of chemotherapy, or endocrine drug) in combination with apatinib mesylate in the treatment of her-2 negative, chest wall metastatic advanced breast cancer, and the present study proposes to further explore the efficacy of apatinib mesylate in her-2 negative, HR-positive advanced breast cancer.
Read the detailed description
In order to further explore the efficacy of apatinib mesylate in advanced breast cancer with negative her-2 and positive HR, this study intends to carry out an observation study on the efficacy of apatinib mesylate combined with doctor's choice scheme in the treatment of advanced breast cancer with negative her-2 and positive HR.
- Conditions
- Advanced Breast Cancer
- Being tested
- apatinib mesylate+Capecitabine Tablets, apatinib mesylate+Fulvestrant injection
- Keywords
- Her-2 negative, HR positive , advanced breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinib mesylate+Capecitabine TabletsDrug
Apatinib Mesylate Tablets: 500 mg, qd, orally until disease progression or intolerable adverse reactions.
Capecitabine Tablets: 1000 mg/m2, po, twice a day, d1-d14, discontinued for 1 week after 2 weeks of treatment;
apatinib mesylate+Fulvestrant injectionDrug
Apatinib Mesylate Tablets: 500 mg, qd, orally until disease progression or intolerable adverse reactions.
Fulvestrant injection 500 mg, intramuscular injection, q4w, once on d1 and d15 in the first cycle;
| Study group | Role | What they receive |
|---|---|---|
| Apatinib mesylate combined with chemotherapy (Capecitabine/vinorelbine) | Experimental | Not described Receives: Drug: apatinib mesylate+Capecitabine Tablets |
| Apatinib mesylate combined with endocrine | Active comparator | Not described Receives: Drug: apatinib mesylate+Fulvestrant injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Huiping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Huiping, Peking University Cancer Hospital & Institute
- Investigators
- Huiping Li, MD, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339281
- Sponsor's protocol ID
- 2023YJZ87
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research plan will be shared after the patient registration is completed.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Apatinib Mesylate in Combination With a Physician's Choice Regimen for Her-2 Negative, HR-positive Progressive Breast Cancer.
- ClinicalTrials.gov ID
- NCT06339281
- Acronym / sponsor ID
- 2023YJZ87
- Conditions
- Advanced Breast Cancer
- Keywords
- Her-2 negative, HR positive , advanced breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Li HuipingUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Apr 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.
Previous studies have found good efficacy of (investigator's choice of chemotherapy, or endocrine drug) in combination with apatinib mesylate in the treatment of her-2 negative, chest wall metastatic advanced breast cancer, and the present study proposes to further explore the efficacy of apatinib mesylate in her-2 negative, HR-positive advanced breast cancer.
Detailed description
In order to further explore the efficacy of apatinib mesylate in advanced breast cancer with negative her-2 and positive HR, this study intends to carry out an observation study on the efficacy of apatinib mesylate combined with doctor's choice scheme in the treatment of advanced breast cancer with negative her-2 and positive HR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib mesylate combined with chemotherapy (Capecitabine/vinorelbine) | Experimental | Drug: apatinib mesylate+Capecitabine Tablets |
| Apatinib mesylate combined with endocrine | Active comparator | Drug: apatinib mesylate+Fulvestrant injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed her-2 negative, HR-positive progressive breast cancer (prior chemotherapy (including adjuvant or neoadjuvant) with anthracycline and/or paclitaxel required);
- No more than 3 lines of chemotherapy for recurrent or metastatic breast cancer;
- Must have progression previously used endocrine therapy and CDK4/6 inhibitors for recurrent or metastatic disease ;
- PET-CT（SUV）>5;
- Age ≥18 years;
Key exclusion criteria (14 listed)
- Received radiation therapy within 28 days prior to enrollment. Radiotherapy for the relief of metastatic bone pain prior to enrollment is permitted, provided that no more than 30% of the total marrow-containing bone is irradiated, with the exception of patients with good bone feel prior to treatment;
- The presence of evidence of central nervous system metastases;
- Current or recent (within 30 days prior to enrollment) use of another investigational drug or participation in another clinical study
- Other malignancy within 5 years (except adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or controlled basal cell carcinoma of the skin)
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacologic therapy)
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 |
|---|---|---|
| apatinib mesylate+Capecitabine TabletsApatinib Mesylate Tablets: 500 mg, qd, orally until disease progression or intolerable adverse reactions. Capecitabine Tablets: 1000 mg/m2, po, twice a day, d1-d14, discontinued for 1 week after 2 weeks of treatment; | Drug | Apatinib mesylate combined with chemotherapy (Capecitabine/vinorelbine) |
| apatinib mesylate+Fulvestrant injectionApatinib Mesylate Tablets: 500 mg, qd, orally until disease progression or intolerable adverse reactions. Fulvestrant injection 500 mg, intramuscular injection, q4w, once on d1 and d15 in the first cycle; | Drug | Apatinib mesylate combined with endocrine |
Primary outcome
Progression-free survival
Time frame: 36 months
Progression-free survival
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 19 Apr 2024.
- Individual participant dataSharing planned: No. The research plan will be shared after the patient registration is completed.
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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.
Huiping Li, MD study chair
Peking University Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing apatinib mesylate+Capecitabine Tablets and apatinib mesylate+Fulvestrant injection in people with Advanced Breast Cancer, run by Li Huiping.
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 13 inclusion and 14 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: opening soon, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Huiping li, MD ((0086)13811012595, huipingli2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 36 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 19 Apr 2024.