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

NCT02829008 | Unknown Phase 2 DMC

• 2 other identifiers: LQ002CAMS-LQOO2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

HER2 negative breast cancer; low-dose bevacizumab; pemetrexed

Outcome Measures

Primary Outcomes (1)

• Objective response rare (ORR)

  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 Outcomes (2)

• progression free survival(PFS)

  up to 48 months

• Overall survival(OS)

  up to 48 months

Study Arms (2)

low-dose-bevacizumab/Pemetrexed

EXPERIMENTAL

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

Treatment of physician' choice

ACTIVE COMPARATOR

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

Interventions

low-dose-bevacizumab/pemetrexed DRUG

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.

Also known as: Avastin/ALIMTA

low-dose-bevacizumab/Pemetrexed

Treatment of physician's choice DRUG

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.

Also known as: any drug or regimen approved in metastatic cancer

Treatment of physician' choice

Eligibility Criteria

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

You may qualify if:

• Metastatic breast cancer females confirmed by pathological and/or cytological examination;
• Breast cancer patients who received taxanes and anthracycline-containing regimens previously;
• HER2-negative breast cancer patients confirmed by immunohistochemical test or fluorescent in situ hybridization(FISH);
• Patients aged from 18-70 years old, and patients with Eastern Cooperative Oncology Group（ECOG） performance status scored 0-2;
• 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;
• 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;
• Patients without any kind of major organ dysfunction: normal blood test results, normal function of heart, liver, kidney, marrow and so on.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (15)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Pemetrexed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• Binghe Xu, MD.

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 3, 2016
• First Posted: July 12, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2020
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

CN (1)