720 Participants Needed

Trastuzumab Emtansine Safety for Cancer

Recruiting at 279 trial locations
RS
RS
Overseen ByReference Study ID Number: BO25430 https://forpatients.roche.com/
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Genentech, Inc.
Must be taking: Trastuzumab emtansine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss your current medications with the study team to get a clear answer.

What data supports the effectiveness of the drug Trastuzumab Emtansine (T-DM1) for cancer?

Trastuzumab Emtansine (T-DM1) has been shown to improve survival in patients with HER2-positive metastatic breast cancer, as demonstrated in the EMILIA trial, where it was compared to other standard treatments. It is generally well tolerated, although some patients may need dose adjustments due to side effects.12345

Is Trastuzumab Emtansine generally safe for humans?

Trastuzumab Emtansine (also known as T-DM1 or Kadcyla) has been studied for safety in treating HER2-positive breast cancer. While it is generally considered safe, it can cause side effects, including serious ones like lung problems, as seen in a case of fatal pneumonia. It's important to discuss potential risks with a healthcare provider.15678

How is the drug Trastuzumab Emtansine (Kadcyla) different from other treatments for HER2-positive breast cancer?

Trastuzumab Emtansine (Kadcyla) is unique because it combines an antibody (trastuzumab) with a chemotherapy drug (emtansine) to specifically target and kill cancer cells, which may result in fewer side effects compared to traditional chemotherapy. It is used for HER2-positive breast cancer that has not responded to other treatments, offering a targeted approach that can be more effective for certain patients.14569

Research Team

CT

Clinical Trials

Principal Investigator

Genentech, Inc.

Eligibility Criteria

This trial is for cancer patients who were previously treated with Trastuzumab Emtansine alone or in combination with other therapies in a related study and are still benefiting. They must not have severe heart issues, uncontrolled diseases, recent major surgeries, current pregnancy/lactation, certain drug allergies, high-grade peripheral neuropathy, or specific adverse reactions from previous treatments.

Inclusion Criteria

I am willing to use effective birth control during and after the study.
I was in a control group for a previous study and my condition worsened, now I can start a new treatment.
My doctor believes I could benefit from more trastuzumab emtansine treatment.
See 2 more

Exclusion Criteria

Inability or unwillingness to comply with the protocol requirements
I do not have any severe, uncontrolled illnesses.
I have not had major surgery or a serious injury in the last 28 days.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trastuzumab emtansine as a single agent or in combination with other anti-cancer therapies in 21-day cycles or weekly, depending on the schedule used in the parent study

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive treatment as long as they are benefiting from it

Long-term

Treatment Details

Interventions

  • Pertuzumab
  • Trastuzumab
  • Trastuzumab Emtansine
Trial OverviewThe trial continues treatment with Trastuzumab Emtansine for those showing benefits from prior studies. It's an open-label extension meaning everyone knows what treatment they're getting. The aim is to assess long-term safety of the drug used alone or with other anti-cancer agents like Paclitaxel and Atezolizumab.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Trastuzumab EmtansineExperimental Treatment6 Interventions
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.

Trastuzumab Emtansine is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as Kadcyla for:
  • Metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received prior therapy with trastuzumab and a taxane, either separately or in combination.
  • Adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment
🇪🇺
Approved in European Union as Kadcyla for:
  • Metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received prior therapy with trastuzumab and a taxane, either separately or in combination.
🇬🇧
Approved in United Kingdom as Kadcyla for:
  • Metastatic breast cancer in patients whose tumors overexpress the HER2 protein and who have received prior therapy with trastuzumab and a taxane, either separately or in combination.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Hoffmann-La Roche

Industry Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Ado-trastuzumab emtansine (T-DM1) was approved in the U.S. for treating HER2 positive metastatic breast cancer based on the EMILIA phase III trial, which showed it was more effective than the standard treatment of lapatinib plus capecitabine.
Ongoing and planned trials are exploring T-DM1's use in various stages of breast cancer, and the review discusses its toxicity management and potential resistance mechanisms, highlighting its importance in current cancer treatment strategies.
Ado-trastuzumab emtansine (T-DM1) in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer: latest evidence and clinical potential.Peddi, PF., Hurvitz, SA.[2022]
In a study of 893 HER2+ advanced breast cancer patients treated with ado-trastuzumab emtansine (T-DM1), early adverse events that required dose interruptions or reductions did not significantly affect overall survival (OS) or progression-free survival (PFS).
The analysis, using data from the EMILIA and TH3RESA clinical trials, indicated that early dose adjustments due to adverse events are not linked to worse long-term outcomes, suggesting that T-DM1 remains an effective treatment option even when dose modifications are necessary.
Effect of early adverse events resulting in ado-trastuzumab emtansine dose adjustments on survival outcomes of HER2+ advanced breast cancer patients.Tang, E., Rowland, A., McKinnon, RA., et al.[2020]
In a study of 128 patients with advanced HER2+ breast cancer treated with ado-trastuzumab emtansine (T-DM1), the median progression-free survival was 8.7 months and overall survival was 20.4 months, indicating its efficacy in a real-world setting.
The safety profile of T-DM1 was consistent with existing literature, but the study noted higher rates of peripheral neuropathy (21.9%) and liver toxicity (19.5%), which are important considerations for its use in treatment.
Safety and efficacy of T-DM1 in patients with advanced HER2-positive breast cancer The Royal Marsden experience.Battisti, NML., Rogerson, F., Lee, K., et al.[2021]

References

Ado-trastuzumab emtansine (T-DM1) in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer: latest evidence and clinical potential. [2022]
Effect of early adverse events resulting in ado-trastuzumab emtansine dose adjustments on survival outcomes of HER2+ advanced breast cancer patients. [2020]
Acute Pancreatitis Associated With Ado-Trastuzumab Emtansine. [2019]
Safety and efficacy of T-DM1 in patients with advanced HER2-positive breast cancer The Royal Marsden experience. [2021]
Biological Evaluation of Maytansinoid-Based Site-Specific Antibody-Drug Conjugate Produced by Fully Chemical Conjugation Approach: AJICAP®. [2022]
Safety Profile and Costs of Related Adverse Events of Trastuzumab Emtansine for the Treatment of HER2-Positive Locally Advanced or Metastatic Breast Cancer Compared to Capecitabine Plus Lapatinib from the Perspective of the Canadian Health-Care System. [2019]
Acute eosinophilic pneumonia: a fatal reaction to ado-trastuzumab. [2023]
Trastuzumab Emtansine: A Review of Its Adjuvant Use in Residual Invasive HER2-Positive Early Breast Cancer. [2022]
Acute skin radiation toxicity seen with concurrent T-DM1: A single institutional report of 35 patients. [2023]