Ado-trastuzumab Emtansine for Breast Cancer

Not currently recruiting at 21 trial locations

Overseen By Angela M. Gosch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: T-DM1

Must not be taking: Neurotoxic anticancer, Neuropathy drugs

Disqualifiers: Previous T-DM1 use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the drug ado-trastuzumab emtansine (T-DM1) affects nerves in individuals with HER2-positive breast cancer. Researchers seek to determine how T-DM1 might cause peripheral neuropathy, a condition that can cause tingling or numbness in the hands and feet. The study seeks participants who will receive T-DM1 for their breast cancer treatment and have not previously used this specific drug. It is suitable for those who have experienced nerve issues before and are ready to try this new treatment. Participants must be able to complete a questionnaire in English. As a Phase 2 trial, this research focuses on measuring T-DM1's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. If you are using specific neurotoxic anticancer agents or drugs for treating peripheral neuropathy, you must stop them at least 7 days before starting the study.

Is there any evidence suggesting that ado-trastuzumab emtansine (T-DM1) is likely to be safe for humans?

Research has shown that ado-trastuzumab emtansine (T-DM1) is generally safe and well-tolerated for treating HER2-positive breast cancer. Studies have identified the most common serious side effects as low platelet counts, higher liver enzyme levels, and anemia, occurring in more than 2% of patients. Despite these risks, overall evidence suggests that T-DM1 is relatively safe for patients with advanced HER2-positive breast cancer. T-DM1 has already received FDA approval for treating this type of cancer, indicating it has passed several safety checks. However, like any treatment, it carries risks, and discussing them with healthcare providers is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ado-trastuzumab emtansine, also known as T-DM1, is unique because it combines the targeted action of trastuzumab with the cancer-killing power of chemotherapy, all in one molecule. Unlike traditional treatments for HER2-positive breast cancer that may involve separate chemotherapy and antibody infusions, T-DM1 links these directly, delivering chemotherapy specifically to cancer cells while sparing more healthy cells. Researchers are excited about this treatment because its targeted delivery could mean fewer side effects and improved outcomes compared to standard treatments like trastuzumab and chemotherapy given separately.

What evidence suggests that ado-trastuzumab emtansine (T-DM1) might be an effective treatment for neuropathy?

Studies have shown that the treatment ado-trastuzumab emtansine (T-DM1) works well for HER2-positive breast cancer. In one study, 75.7% of patients responded positively, and 12.8% had a complete response, meaning their cancer was no longer detectable. Another study found that T-DM1 cut the risk of cancer returning or causing death by half. Overall, research indicates that this treatment effectively helps patients manage their condition, making it a promising option for those with HER2-positive breast cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Dan S. Childs, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Inclusion Criteria

Planning to receive three or more doses T-DM1 for HER2-positive metastatic breast cancer (any line) or for earlier-stage breast cancer. The patient may have received one dose of T-DM1, prior to study entry if it has not been longer than 14 days since that dose and that the patient will be able to complete the required baseline questionnaire within 14 days of their first dose of T-DM1.

Patients with previous use of neurotoxic antineoplastic agents (excluding previous use of T-DM1), pre-existing CIPN, or peripheral neuropathy secondary to other causes will be able to be enrolled in the study.

The patient plans to continue clinical follow-up at the same institution, where the patient entered the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants are observed for the natural history of T-DM1-induced neuropathy

22 months

Follow-up

Participants are monitored for safety and effectiveness after observation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ado-trastuzumab Emtansine (T-DM1)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40437155/

Real-world data on trastuzumab emtansine (TDM1) ... The objective response rate was 75.7%, with 12.8% achieving a complete response and 62.8% a partial response. PFS was significantly longer in ...

2. nature.com nature.com/articles/s41598-025-97923-2

Real-world data on trastuzumab emtansine (TDM1) ... This study aims to provide real-world evidence on the efficacy and safety of TDM1 in HER2-positive MBC patients.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1814017

Trastuzumab Emtansine for Residual Invasive HER2 ... In this trial, adjuvant treatment with T-DM1 resulted in a 50% lower risk of recurrence of invasive disease or death than adjuvant continuation ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e13008

Safety, efficacy and survival outcome of Ado-trastuzumab ... The overall response rate was 80%, 8(10%) achieved a complete response, 36 (45%) had a partial response, and 12 (15%) patients had stable ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10232689/

Retrospective Observational Study of Outcomes in HER2 ... Limited evidence exists on real-world outcomes with ado-trastuzumab emtansine (T-DM1) treatment and the effectiveness of subsequent therapies.

6. kadcyla-hcp.com kadcyla-hcp.com/safety.html

KADCYLA Indications and Important Safety Information In EMILIA, the most common NCI–CTCAE (version 3) Grade ≥ 3 adverse reactions (frequency >2%) were thrombocytopenia, increased transaminases, anemia, hypokalemia ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5803744/

Adverse Events of Trastuzumab Emtansine (T-DM1) in ... - PMC Overall, the currently available data suggest that T-DM1 is a relatively safe and well-tolerated agent in the treatment of metastatic HER2-positive BC.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2949820124000237

Utilization and safety of trastuzumab emtansine (T-DM1) T-DM1 users have increased risks of hospitalisation for thrombocytopenia. •. Metastatic patients treated with T-DM1 had a median OS of 32.6 months in this study ...

9. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)00343-2/fulltext

Safety profile of trastuzumab-emtansine (T-DM1) with ... The combination of T-DM1 and RT shows safety in terms of acute skin effects and pneumonitis. •. The field is currently awaiting international ...