T-DXd Combinations for Breast Cancer

(DB-07 Trial)

Recruiting in Palo Alto (17 mi)

+75 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

Eligibility Criteria

This trial is for adults with HER2-positive metastatic breast cancer that's advanced or can't be surgically removed. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory. They should not have had certain prior treatments, need to have progressed after their last systemic therapy, and may only have stable brain metastases or none at all.

Inclusion Criteria

I have received at least one treatment for my cancer after it spread.

I have brain metastases that haven't been treated or have worsened after treatment.

My cancer cannot be removed by surgery and has spread.

Exclusion Criteria

I have been treated with tucatinib before.

I have no serious lung illnesses besides my cancer.

I have been treated with drugs that boost the immune system.

Participant Groups

DESTINY-Breast07 explores the effectiveness of trastuzumab deruxtecan (T-DXd) combined with other anti-cancer drugs like Tucatinib, Durvalumab, Paclitaxel, and Pertuzumab in treating HER2-positive metastatic breast cancer. The study aims to assess safety and how well tumors respond to these combinations.

Group I: Module 7 - T-DXd Experimental Treatment 1 Intervention

T-DXd monotherapy in patients with active brain metastases (Part 2 Only)

Group II: Module 6 - T-DXd and Tucatinib Experimental Treatment 2 Interventions

T-DXd and tucatinib in patients with active brain metastases (Part 2 Only) (Arm not initiated)

Group III: Module 5 - T-DXd and Tucatanib Experimental Treatment 2 Interventions

T-DXd and tucatinib (Arm not initiated in Part 2)

Group IV: Module 4- T-DXd and Durvalumab and Paclitaxel Experimental Treatment 3 Interventions

T-DXd and Durvalumab and Paclitaxel (Arm not initiated in Part 1 and Part 2)

Group V: Module 3- T-DXd and Paclitaxel Experimental Treatment 2 Interventions

T-DXd and Paclitaxel (Arm not initiated in Part 2)

Group VI: Module 2- T-DXd and Pertuzumab Experimental Treatment 2 Interventions

T-DXd and Pertuzumab

Group VII: Module 1- T-DXd and Durvalumab Experimental Treatment 2 Interventions

T-DXd and Durvalumab

Group VIII: Module 0- T-DXd Experimental Treatment 1 Intervention

T-DXd

Pertuzumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

🇺🇸 Approved in United States as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

🇨🇦 Approved in Canada as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

🇯🇵 Approved in Japan as Perjeta for:

• Early breast cancer
• Metastatic breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site Providence, RI

Research Site Saint Paul, MN

Research Site Middletown, NJ

Research Site Montvale, NJ

More Trial Locations

Who Is Running the Clinical Trial?

AstraZeneca Lead Sponsor

Daiichi Sankyo Company, Limited Collaborator

References