RecruitingPhase 3

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

United States100 participantsStarted 2025-10-30

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant must be ≥ 18 years (and above legal age) at the time of screening.
✓. Inoperable or metastatic HR-positive, HER2 IHC 0 breast cancer (per ASCO/CAP guidelines, on local laboratory results); ie, is documented as HR-positive (either ER and/or PgR positive \[ER or PgR ≥ 1%\]) and HER2 IHC 0 (defined as no staining or incomplete and faint/barely perceptible membrane staining in ≤ 10% of tumour cells).
✓. Progressed on and not suitable for further endocrine therapy per investigator assessment.
✓. ECOG performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to the first dose of study intervention.
✓. Minimum life expectancy of 12 weeks at screening.
✓. Provision of acceptable tumour sample (no more than 6 weeks old) prior to the first dose of study intervention or retrospectively as defined in the Laboratory Manual and the Diagnostic Testing Manual
✓. Participants must have measurable disease as per RECIST 1.1 or evaluable disease. Lesions that will be subject to mandatory biopsy before, during, and after the dosing cannot be considered as TLs as per RECIST requirements.
✓. Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention.

Exclusion criteria

✕. Calculated CrCL ≥ 30 mL/min as determined by Cockcroft Gault (using actual body weight).
✕. Male and/or female assigned at birth, inclusive of all gender identities.
✕0. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies;
✕1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this CSP.
✕2. All races, genders, and ethnic groups are eligible for this study.
✕. As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases and significant cardiac or psychological conditions), history of allogenic organ transplant, and/or substance abuse which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
✕. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non melanoma skin cancer (basal cell carcinoma of the skin or squamous cell carcinoma of the skin) and curatively treated in situ disease.
✕. Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Note: participants may be enrolled with some chronic, stable Grade 2 toxicities (defined as no worsening to Grade \> 2 for at least 3 months prior to the first dose of study intervention and managed with SoC treatment) which the investigator deems related to previous anticancer therapy):

What they're measuring

Progression Free Survival (PFS) per RECIST 1.1 as assessed by the investigator

Timeframe: 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

Trial details

NCT IDNCT07205822

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02-02

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Breast Cancer trials