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

NCT06339281 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023YJZ87
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Breast Cancer

Keywords

Her-2 negative, HR positive , advanced breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival

  36 months

Study Arms (2)

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

Interventions

apatinib mesylate+Capecitabine Tablets DRUG

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 combined with chemotherapy (Capecitabine/vinorelbine)

apatinib mesylate+Fulvestrant injection DRUG

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;

Apatinib mesylate combined with endocrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Li Huiping: lead

Study Officials

• Huiping Li, MD

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Central Study Contacts

Huiping li, MD

CONTACT

(0086)13811012595; huipingli2012@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of breast oncology department

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 1, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share