Anrotinib in Combination With Capecitabine in Advanced Triple Negative Breast Cancer

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05089643
Collaborator
(none)
35
2
1
44.7
17.5
0.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anrotinib in Combination With Capecitabine in the Single-arm, Open Phase II Treatment of Relapsed or Metastatic Triple-negative Breast Cancer Clinical Research
Actual Study Start Date :
Apr 11, 2019
Actual Primary Completion Date :
Apr 15, 2019
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CA

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

Drug: Anlotinib
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.

Drug: Capecitabine
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.

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate [up to 1 year after the last patient enrolled]

    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)

Secondary Outcome Measures

  1. Progression-free survival [up to 1 year after the last patient enrolled]

    PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause

  2. adverse events [approximately 1.5 years]

    Incidence and Severity of adverse events hematologic,hepatotoxicity,Incidence of hypertension,Incidence of proteinuria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Female aged between 18 and 70;

  2. 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.

  3. 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;

  4. There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)

Exclusion Criteria:
  1. The number of previous treatment lines (including postoperative adjuvant therapy) >4 lines

  2. 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).

  3. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing China 100021
2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing China 100021

Sponsors and Collaborators

  • Chinese Academy of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peng Yuan, Chief of VIP department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05089643
Other Study ID Numbers:
  • NCC1969
First Posted:
Oct 22, 2021
Last Update Posted:
Jan 10, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2022