Anrotinib in Combination With Capecitabine in Advanced Triple Negative Breast Cancer

NCT05089643 | Unknown Phase 2

• 1 other identifier: NCC1969
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC. It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer

Conditions

Metastatic Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  he ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)

  up to 1 year after the last patient enrolled

Secondary Outcomes (2)

• Progression-free survival

  up to 1 year after the last patient enrolled

• adverse events

  approximately 1.5 years

Study Arms (1)

CA

EXPERIMENTAL

Anlotinib 10mg Qd D1-14 Capecitabine 1G /m2 Bid D1-14 / Q21D

Drug: Anlotinib; Drug: Capecitabine

Interventions

Anlotinib DRUG

Before breakfast, anlotinib hydrochloride capsule was taken on an empty stomach, once a day, 1 tablet (10mg) each time.Continuous oral administration for 2 weeks stopped for 1 week, that is, 3 weeks (21 days) as a treatment cycle, until disease progression or adverse reactions become intolerable.In case of missing medication, confirm that the time before the next medication is less than 12 hours, no refill.

CA

Capecitabine DRUG

Capecitabine tablets 1000 mg/m2, twice a day, within 30min after meals, were taken orally for 2 consecutive weeks and stopped for 1 week, i.e., 3 weeks (21 days) as a treatment cycle until disease progression or adverse reactions became intolerable.

CA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged between 18 and 70;
• Recurrence or metastasis OF TNBC confirmed by histological or cytological methods, TNBC definitions of ER, PR and HER-2 are negative, if there is metastasis pathology, the histological pathology of metastasis shall prevail.ER and PR negative were defined as ER \< 10% positive and PR \< 10% positive.
• Disease progression after at least one prior systemic treatment and anthracycline and/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or disease progression during treatment or within 6 months of discontinuation of treatment should be counted as first-line systemic treatment failure;
• There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)

You may not qualify if:

• The number of previous treatment lines (including postoperative adjuvant therapy) \>4 lines
• symptomatic central system metastases.Patients with stable asymptomatic BMS who have received brain radiation and who have at least one other evaluable target in addition to the BMS can be enrolled (evaluable target should be at least 4 weeks away from the last radiotherapy).
• New bisphosphonate or dinoselmer treatment for bone metastases was initiated within 28 days prior to study initiation.(Subjects are permitted if they have already been treated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stable administration prior to study initiation.)Subjects already enrolled in this study may begin treatment with bisphosphonate or dinoselmer for bone metastases after the first post-treatment evaluation

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

anlotinib; Capecitabine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Peng Yuan, doctor

CONTACT

18612621749; sunlight_1985@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of VIP department

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 22, 2021
• Study Start: April 11, 2019
• Primary Completion: April 15, 2019
• Study Completion: December 31, 2022
• Last Updated: January 10, 2022

Record last verified: 2021-12

Locations

CN (2)