Anlotinib in Metastatic HER2 Negative Breast Cancer

NCT04002284 | Completed Phase 2

• 1 other identifier: NCC1692
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is to discover if the anlotinib can shrink or slow the growth of pretreated HER2 negative metastatic breast cancer.

Conditions

Breast Neoplasm; Antineoplastic Agents; Anlotinib

Outcome Measures

Primary Outcomes (1)

• objective response rate(ORR)

  Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• disease control rate(DCR)

  through study completion, an average of 1 year

• Progression free survival (PFS)

  From date of enrollment until the date of first documented progression, assessed up to 24 months

• overall survival(OS)

  From date of enrollment until death, assessed up to 24 months

• Safety and Tolerability

  through study completion, an average of 1 year

Other Outcomes (1)

• circulating tumor DNA biomarker

  From date of enrollment until the date of first documented progression, assessed up to 24 months

Study Arms (1)

anlotinib

EXPERIMENTAL

anlotinib 12mg qd p.o. d1-14/21day/cycle

Drug: Anlotinib Hydrochloride

Interventions

Anlotinib Hydrochloride DRUG

Anlotinib 12mg p.o. d1-14, 21days/cycle

Also known as: anlotinib

anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; HER2 negative(immunohistochemistry or fluorescence in situ hybridization);
• ECOG score: 0-1, expected survival time ≥ 3months;
• Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-2 standard chemotherapies after recurrence and metastasis;
• According to RECIST 1.1, exist at least ≥1 measurable lesion(CT \>1cm，other examination \>2cm);
• The patients have enough organ function. The laboratory test indexes must comply with the following requirements:
• Blood routine: neutrophil≥1.5G/L, platelet count ≥80G/L, hemoglobin ≥90g/L Liver function: serum bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper limit of normal value when liver metastasis Renal function: serum creatinine ≤ 1.0times the upper limit of normal value, creatinine clearance \>50ml/min（Cockcroft-Gault formula)
• Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial and 8 weeks after last administration；
• Can swallow oral drugs;
• The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.

You may not qualify if:

• The patients in pregnancy or lactation growth period and did not take effective contraception;
• The patients who received ≥3 chemotherapies（Do not include endocrine therapy）after recurrence and metastasis; involved in other clinical trials four weeks prior to the start of the study;
• The patients with a variety of factors that affect the oral administration and absorption of drugs;
• The patients with rapid progression of viscera invasion(liver lesion \>1/2 viscera area or liver dysfunction);
• The patients have uncontrollable mental illness.
• The patients who had serious adverse effect to oral etoposide or were allergic to etoposide.
• The patients who have only bone metastasis without other measurable lesion;
• The patients experience severe cardiovascular diseases;
• The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome.
• Abnormal bone marrow functions(neutrophil\<1.5G/L, platelet count \<75G/L, hemoglobin \<90g/L);
• Abnormal renal function(serum creatinine \> 1.5 times the upper limit of normal value);
• Abnormal liver function(serum bilirubin ≤ 1.5 times the upper limit of normal value);
• The patients have uncontrollable brain metastasis;
• The patients do not have good compliance to the therapy.

Sponsors & Collaborators

• Peng Yuan: lead

Study Sites (1)

National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Peng Yuan

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 28, 2019
• Study Start: July 12, 2018
• Primary Completion: January 10, 2020
• Study Completion: March 15, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)