Trastuzumab Deruxtecan for Metastatic Breast Cancer

Recruiting in Palo Alto (17 mi)

+207 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Daiichi Sankyo

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial will compare trastuzumab deruxtecan to other treatments for patients with HER2-low breast cancer that cannot be removed by surgery and has spread. The treatment targets and kills cancer cells by delivering chemotherapy directly to them. Trastuzumab deruxtecan has shown effectiveness in patients with HER2-low breast cancer, resulting in longer periods without the disease getting worse and longer life expectancy compared to other chemotherapy treatments.

Eligibility Criteria

This trial is for adults with HER2-low breast cancer that's inoperable or has spread, and who have tried endocrine therapy without success. They should have had 1-2 prior chemotherapy treatments in the metastatic setting, be able to provide tumor samples, and not have high-HER2 cancer or a history of certain lung conditions.

Inclusion Criteria

I can provide samples of my tumor for testing before treatment starts.

My cancer has grown or spread on my latest scans.

My cancer has low levels of HER2.

See 9 more

Exclusion Criteria

I have been treated with a HER2-targeting therapy before.

I have spinal cord compression or active brain metastases.

My breast cancer has high levels of HER2.

See 4 more

Treatment Details

Interventions

Capecitabine (Other)
Eribulin (Other)
Gemcitabine (Other)
Nab-paclitaxel (Other)
Paclitaxel (Other)
Trastuzumab (Monoclonal Antibodies)
Trastuzumab deruxtecan (DS-8201a) (Monoclonal Antibodies)

Trial OverviewThe study compares DS-8201a (Trastuzumab Deruxtecan) with standard treatments chosen by physicians such as Eribulin, Paclitaxel, Gemcitabine, Capecitabine or Nab-paclitaxel. Participants will receive either the new drug or one of these existing drugs based on their doctor's choice.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Trastuzumab deruxtecanExperimental Treatment1 Intervention

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to DS8201a

Group II: Physician's ChoiceActive Control5 Interventions

HER2-low, unresectable, and/or metastatic breast cancer participants previously treated with chemotherapy randomized to Physician's choice from the following options: * Capecitabine * Eribulin * Gemcitabine * Paclitaxel * Nab-paclitaxel

Trastuzumab deruxtecan (DS-8201a) is already approved in United States, European Union, Japan, Australia for the following indications:

🇺🇸 Approved in United States as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma
Unresectable or metastatic HER2-low breast cancer
Unresectable or metastatic HER2-positive solid tumors

🇪🇺 Approved in European Union as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma

🇯🇵 Approved in Japan as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma

🇦🇺 Approved in Australia as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma