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Trial Title:
A Multicenter Clinical Study of Apatinib Mesylate Combined With Doctor's Choice for Advanced Breast Cancer
NCT ID:
NCT06339281
Condition:
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Capecitabine
Apatinib
Fulvestrant
Conditions: Keywords:
Her-2 negative, HR positive , advanced breast cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
apatinib mesylate+Capecitabine Tablets
Description:
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;
Arm group label:
Apatinib mesylate combined with chemotherapy (Capecitabine/vinorelbine)
Intervention type:
Drug
Intervention name:
apatinib mesylate+Fulvestrant injection
Description:
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;
Arm group label:
Apatinib mesylate combined with endocrine
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria：
1. Histologically or cytologically confirmed her-2 negative, HR-positive progressive
breast cancer (prior chemotherapy (including adjuvant or neoadjuvant) with
anthracycline and/or paclitaxel required);
2. No more than 3 lines of chemotherapy for recurrent or metastatic breast cancer;
3. Must have progression previously used endocrine therapy and CDK4/6 inhibitors for
recurrent or metastatic disease ;
4. PET-CT（SUV）>5;
5. Age ≥18 years;
6. ECOG PS 0-1;
7. life expectancy ≥ 3 months
8. 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;
9. Appropriate hematopoiesis；
10. Appropriate liver function；
11. Appropriate renal function；
12. Normal coagulation;
13. Females of childbearing potential willing to use contraception during the trial:
negative serum or urine pregnancy test within 7 days prior to dosing.
Exclusion Criteria:
1. 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;
2. The presence of evidence of central nervous system metastases;
3. Current or recent (within 30 days prior to enrollment) use of another
investigational drug or participation in another clinical study
4. 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)
5. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood
pressure ≥ 90 mmHg despite optimal pharmacologic therapy)
6. 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);
7. Grade III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound
suggesting left ventricular ejection fraction (LVEF) <50%;
8. 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;
9. 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
10. Have undergone major surgical procedures or have sustained a severe traumatic
injury, fracture, or ulcer within the previous 4 weeks
11. Having factors that significantly affect the absorption of oral medication, such as
inability to swallow, chronic diarrhea and intestinal obstruction, etc;
12. Urine routine suggestive of urinary protein ≥ ++, or confirmed 24-hour urine protein
volume ≥ 1.0 g;
13. Plasmapheresis (including pleural fluid, ascites, and pericardial effusion) that is
clinically symptomatic and requires surgical management;
14. Other conditions that, in the judgment of the investigator, may affect the conduct
of the clinical study and the determination of the study results.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Li Huiping
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06339281
