A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer

Part of paid clinical trials in Largo, Florida.

Sponsor
AstraZeneca
Study ID
NCT07205822
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dato-DXd — DRUG
    All participants will receive Dato-DXd (6 mg/kg IV on Day 1, Q3W; up to a maximum of 540 mg Q3W for participants ≥ 90 kg) until investigator-defined disease progression according to RECIST 1.1 or until unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met. Continued treatment with the same study drug post-progression may be allowed, based on prior discussion with sponsor/sponsor representative/study physician on a case-by-case basis following written investigator's confirmation of continuing clinical benefit to the patient post progression. The study is anticipated to enrol for an 18-month period, and DCO is expected to occur approximately 6 months after the last participant has been dosed.

Study Details

A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.

Key Dates

Start date
Oct 30, 2025
Status verified
May 2026
Primary completion
Feb 2, 2028
Completion
Feb 2, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single arm group
    All participants will receive Dato-DXd (6 mg/kg IV on Day 1, Q3W; up to a maximum of 540 mg Q3W for participants ≥ 90 kg) until investigator-defined disease progression according to RECIST 1.1 or until unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.

Primary Outcome Measure

Progression Free Survival (PFS) per RECIST 1.1 as assessed by the investigator [ Time Frame: From date of first dose of study intervention until disease progression per RECIST 1.1 or death from any cause, whichever occurs first, assessed up to approximately 24 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteLargoFlorida33770-
Research SiteFort WayneIndiana46825-
Research SiteOmahaNebraska68130-
Research SiteNew YorkNew York10021-
Research SiteHoustonTexas77024-
Research SitePuyallupWashington98373-

Find similar trials in Largo, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Largo, FLResearch Site· Fort Wayne, INResearch Site· Omaha, NEResearch Site· New York, NYResearch Site· Houston, TXResearch Site· Puyallup, WA

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