A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

Conditions

• Neoplasm Metastasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Docetaxel — DRUG
  Docetaxel will be administered as per local prescribing information.
• Paclitaxel — DRUG
  Paclitaxel will be administered as per local prescribing information.
• Pertuzumab — DRUG
  Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).
• Trastuzumab — DRUG
  Trastuzumab will be administered as per local prescribing information.
• Trastuzumab Emtansine — DRUG
  Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).
• Atezolizumab — DRUG
  Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)

Study Details

This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

Key Dates

Start date

Oct 16, 2008

Status verified

Dec 2025

Primary completion

Sep 30, 2029

Completion

Apr 30, 2030

Study Design

Enrollment

720 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Trastuzumab Emtansine
  Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (atezolizumab, paclitaxel, trastuzumab and docetaxel). Participants will receive the same dose and schedule on Cycle 1, Day 1 at which it was given at the end of the parent study. Study drug will be administered in 21-day cycles or weekly, depending on the schedule used in the parent study. Participants will receive study treatment until disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years) ]

Locations (49)

Find similar trials in Duarte, CA

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