A clinical trial to study the effects of Two Humanized Monoclonal Antibodies that Target HER2 Receptors in Combination with Weekly Paclitaxel in Patients with HER2-Positive Metastatic Breast Cancer.

Phase 3

Completed

• Conditions: Health Condition 1: null- HER2-Positive Metastatic Breast Cancer (MBC)

• Registration Number: CTRI/2015/08/006085
• Lead Sponsor: Dr Reddys Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•Female patients -18 to 75 years of age.

•Histologically or cytologically confirmed metastatic breast cancer.

ï?· Metastatic disease, at least M1 as per AJCC TNM classification.

ï?· Histopathology is recommended to be performed at local laboratory to confirm the metastatic disease, if no previous reports available.

ï?· In case historical reports of histopathology

confirming evidence of breast cancer (primary/metastatic) are available, a repeat biopsy is not required.

ï?· In case of metastatic lesions such as a solitary metastatic nodule or a solitary lymph node, biopsy must be performed to confirm metastatic breast cancer

•Strong HER2-positive status - 3+ score by IHC - to be confirmed at a pre-identified qualified laboratory.

•At least one measurable lesion as per RECIST 1.1, in an area/region that has not been irradiated before.

•ECOG performance status of 0, 1 or 2.

•Life expectancy of more than 3 months in the opinion of the Investigator.

•LVEF >= 50% by echocardiography or MUGA

Exclusion Criteria

•Male patients with metastatic breast cancer.

•H/o prior invasive malignancy, except breast cancer or non-melanoma skin cancer radically resected and non-recurring, at least 1 year prior to randomization.

•Breast cancer metastases in central nervous system.

•Patients who had received prior chemotherapy, hormonal therapy or radiotherapy for their metastatic disease or any prior taxanes or anti-HER2 therapy are excluded, except:

ï?· (neo) adjuvant anthracycline administered 6 months prior to randomization is allowed;

ï?· (neo) adjuvant taxanes administered 12 months prior to randomization is allowed

ï?· (neo)adjuvant trastuzumab or any other monoclonal antibody administered 12 months prior to randomization is allowed;

ï?· Hormonal therapy administered in neo(adjuvant) setting only or as a maintenance therapy after neo(adjuvant) treatment;

ï?· Previous radiotherapy in neo (adjuvant) setting only if treatment has ended 6 months prior to randomization, is allowed.

•Any cardiac disease (history of and/or active disease); Severe uncontrolled hypertension

•Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy

•Sensory or motor neuropathy

•Acute or active chronic infections which, may affect patient safety or participation in the study

•Known hepatitis C virus, hepatitis B virus, HIV infection

•Known hypersensitivity/allergy to trastuzumab, paclitaxel or any excipients

•Known history of drug/alcohol abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified