Low -Dose-bevacizumab and Pemetrexed Versus TPC in Metastatic HER2-negative Breast Cancer Patients

July 11, 2016 updated by: Li Qiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Phase 2 Clinical Trial:Low -Dose-bevacizumab and Pemetrexed Versus Treatment of Physician's Choice in Metastatic HER2-negative Breast Cancer Patients After Failure of Taxanes and Anthracycline-containing Regimens

This is a single-center, open, randomized, controlled phase 2 clinical trial designed to compare low-dose-bevacizumab and pemetrexed with TPC in metastatic HER2-negative breast cancer patients after failure of taxanes and anthracycline-containing regimens.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There is no standard therapy for advanced human epidermal growth factor receptor 2 (HER2) -negative breast cancer patients after failure of taxanes and anthracycline-containing regimens at present. Pemetrexed is a multitargeted antimetabolite. Its efficacy in metastatic breast cancer has been confirmed in several small sample size studies and meta-analyses. Its response rate (RR) is about 30%, and will be higher in HER2-negative breast cancer. However, there is no study focused on this subtype of breast cancer. Bevacizumab is also an effective alternative for metastatic breast cancer. Several studies indicate that the combination of bevacizumab and chemotherapy could improve both RR and overall survival, but its use is confined by its severe side effect and far from adequate treatment. Recent years, a lot of studies have assessed the efficacy of metronomic chemotherapy. Metronomic therapy refers to the chronic administration of low doses of cytotoxic drugs at close, regular intervals. It could promote the apoptosis of tumor endothelial cell , continuously inhibit tumor angiogenesis, and exhibit a significant superiority of low toxicity, reduced cost and prolonged combination therapy period. According to reports in literature, the expression of anti-angiogenic biomarkers, such as,vascular endothelial growth factor(VEGF)-A, VEGF-C, soluble vascular endothelial growth factor receptor (sVEGFR)-1, sVEGFR-2,thrombospondin-1(TSP-1), platelet factor 4 (PF-4) might be concerned with the efficacy of metronomic therapy. Since there are no reported clinical trials according to metronomic bevacizumab in HER2-negative breast cancer, the investigators come up with this study. In this study, the investigators try to make a comparison of the efficacy and safety of low-dose-bevacizumab and pemetrexed with treatment of physician's choice (TPC) in metastatic breast cancer after failure of taxanes and anthracycline-containing regimens, to validate the correlative biomarkers and to find an optimal choice for previously treated metastatic breast cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Hospital, ChineseAMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Metastatic breast cancer females confirmed by pathological and/or cytological examination;
  2. Breast cancer patients who received taxanes and anthracycline-containing regimens previously;
  3. HER2-negative breast cancer patients confirmed by immunohistochemical test or fluorescent in situ hybridization(FISH);
  4. Patients aged from 18-70 years old, and patients with Eastern Cooperative Oncology Group（ECOG） performance status scored 0-2;
  5. One or more measurable lesions in imaging examination,with a diameter no less than 20mm in ordinary computed tomography (CT) or magnetic resonance imaging (MRI), or a scanning diameter no less than 10mm in spiral CT;
  6. Any other kind of concomitant chemotherapy is not allowed during the research. If the patients had accepted other chemotherapy before recruitment, he can enter into the study until the drug is eliminated 30 days later;
  7. Patients without any kind of major organ dysfunction: normal blood test results, normal function of heart, liver, kidney, marrow and so on.

Exclusion Criteria:

  1. Patients who had received any chemotherapy, radiotherapy, biotherapy, or drugs and physical treatment in other clinical trials four weeks within the enrollment;
  2. Patients who has no measurable or assessable lesions ;
  3. Patients with moderate or severe liver dysfunction
  4. Pregnant or lactational patients;
  5. Patients with severe complications, including severe heart disease, cerebrovascular disease, uncontrolled diabet and hypertension, severe infection , active peptic ulcer and so on;
  6. Patient who had previously received pemetrexed-containing regimens in metastatic setting.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low-dose-bevacizumab/Pemetrexed
Low-dose-bevacizumab is given at a dose of 2 mg/kg once weekly by intravenous transfusion, which is on day 1, 8 and 15, and every three weeks are a treatment cycle .Pemetrexed is given at a dose of 500mg/m2 once on the first day by intravenous transfusion, and repeated every three weeks, too. The pretreatment of pemetrexed should be conducted within the study.
Drug: low-dose-bevacizumab/pemetrexed
Bevacizumab is administrated at a dose of 2 mg/kg once weekly by intravenous transfusion, which is on day 1, 8 and 15, and pemetrexed is given at a dose of 500mg/m2 once on the first day by intravenous transfusion, and repeated every three weeks, too.
Other Names:
  • Avastin/ALIMTA
Active Comparator: Treatment of physician' choice
Treatment of physician's choice can be any drug or regimen that has been approved in metastatic cancer at present, including monotherapy, combination therapy, target therapy and palliative therapy. It can be drugs like taxanes,capecitabine, gemcitabine, cisplatin, everolimus or even nutrient solution,et al.
Drug: Treatment of physician's choice
The clinicians can select any drug or regimen that has been approved in metastatic cancer at present, including monotherapy, combination therapy, target therapy and palliative therapy. Specific agents include taxanes, capecitabine, gemcitabine, vinorelbine, cisplatin,carboplatin, nutrient solutions, and so on. These agents can be administered as monotherapy or in combination.
Other Names:
  • any drug or regimen approved in metastatic cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rare (ORR)
Time Frame: up to 24 months
Evaluated as complete remission(CR) and partial remission(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1
up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
progression free survival(PFS)
Time Frame: up to 48 months
up to 48 months
Overall survival(OS)
Time Frame: up to 48 months
up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Binghe Xu, MD., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

July 3, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LQ002
  • CAMS-LQOO2 (Other Identifier: CAMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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