T-DXd Combinations for Breast Cancer
(DB-08 Trial)

Recruiting in Palo Alto (17 mi)

+42 other locations

Komal Jhaveri, MD, FACP - MSK Breast ...

Overseen byKomal Jhaveri

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing T-DXd with other treatments in patients with a specific type of advanced breast cancer that has low levels of HER2. The study aims to find the best dose and see how well the treatment works and how safe it is. T-DXd is a new treatment that has shown promising outcomes in various studies for advanced breast cancers with different levels of HER2.

Research Team

Komal Jhaveri

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with HER2-low advanced or metastatic breast cancer. Eligible patients must have received certain prior treatments depending on their hormone receptor status, and should not have significant lung disease, uncontrolled infections or illnesses, cardiovascular issues, a history of specific lung conditions, primary immunodeficiency, spinal cord compression or active brain metastases.

Inclusion Criteria

I have HR- breast cancer and have had specific prior treatments depending on the study part.

If you have hormone receptor-positive breast cancer, for Part 1, you must have had at least one treatment with hormonal therapy, with or without a targeted therapy, and at least one treatment with chemotherapy for metastatic breast cancer. For Part 2, you can have only one prior treatment with hormonal therapy, with or without a targeted therapy, and no prior chemotherapy in the metastatic setting.

I am 18 years old or older.

See 3 more

Exclusion Criteria

I have or had lung inflammation treated with steroids, or it can't be ruled out by scans.

I have been treated with a specific drug that targets cancer cells.

I do not have any uncontrolled illnesses.

See 5 more

Treatment Details

Interventions

Anastrozole (Hormone Therapy)
Capecitabine (Chemotherapy)
Capivasertib (Other)
Durvalumab (Monoclonal Antibodies)
Fulvestrant (Hormone Therapy)
Paclitaxel (Chemotherapy)
Trastuzumab deruxtecan (Monoclonal Antibodies)

Trial OverviewThe DESTINY-Breast 08 study tests the combination of T-DXd (Trastuzumab deruxtecan) with other therapies like Fulvestrant, Durvalumab, Capivasertib, Anastrozole, Paclitaxel and Capecitabine in treating HER2-low advanced/metastatic breast cancer to evaluate safety and early anti-tumor effects.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: Module 5: T-DXd + fulvestrantExperimental Treatment2 Interventions

T-DXd: 5.4 mg/kg Q3W, intravenous use Fulvestrant: 500 mg Q4W, intramuscular use

Group II: Module 4: T-DXd + anastrozoleExperimental Treatment2 Interventions

T-DXd: 5.4 mg/kg Q3W, intravenous use Anastrozole: 1 mg daily, oral

Group III: Module 3: T-DXd + capivasertibExperimental Treatment2 Interventions

T-DXd: 5.4 mg/kg Q3W, intravenous use Capivasertib: 400 mg BID, oral use

Group IV: Module 2: T-DXd + durvalumab + paclitaxelExperimental Treatment3 Interventions

T-DXd: 5.4 mg/kg Q3W, intravenous use Durvalumab: 1120 mg Q3W, intravenous use Paclitaxel: 80 mg/m2 QW in 3-week cycles, intravenous use

Group V: Module 1: T-DXd + capecitabineExperimental Treatment2 Interventions

T-DXd: 5.4 mg/kg Q3W, intravenous use Capecitabine: 1000mg/m2 BID, days 1-14 Q3W, oral use

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

🇪🇺 Approved in European Union as Arimidex for:

Breast cancer
Early breast cancer in postmenopausal women

🇺🇸 Approved in United States as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer

🇨🇦 Approved in Canada as Arimidex for:

Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

🇯🇵 Approved in Japan as Arimidex for: