A Multicenter Clinical Study of Apatinib Mesylate Combined With Doctor's Choice for Advanced Breast Cancer

Phase 2

Not yet recruiting

• Conditions: Advanced Breast Cancer
• Interventions: Drug: apatinib mesylate+Capecitabine Tablets; Drug: apatinib mesylate+Fulvestrant injection

• Registration Number: NCT06339281
• Lead Sponsor: Li Huiping

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-24
• Status Verified: 2024-04
• Study First Posted: 2024-04-01
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Study Start: 2024-05-01
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apatinib mesylate combined with chemotherapy (Capecitabine/vinorelbine)	apatinib mesylate+Capecitabine Tablets	-
Apatinib mesylate combined with endocrine	apatinib mesylate+Fulvestrant injection	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	36 months	Progression-free survival