BridgeMD
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
EU CTIS ID: 2025-521904-23-00
What this study is testing
To assess efficacy of Dato-DXd by Progression-Free Survival (PFS)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 including HER2 null with no staining or incomplete and faint/barely perceptible membrane staining in ≤ 10% of tumour cells) based on a fresh, or recent tissue sample obtained no more than 6 weeks prior to or during the screening period.
- Progressed on and/or not suitable for further endocrine-based 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 (newly acquired tumour biopsy at baseline or a tumour biopsy sample collected within 6 weeks prior to screening)
- 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.
You likely can't join if
- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases and ongoing or active infection), 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.
- Has clinically severe pulmonary function compromise (ie, requiring any supplemental oxygen), resulting from intercurrent pulmonary illnesses including but not limited to the following: (a) Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial enrolment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc) (b) Any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis, etc) (c) Prior pneumonectomy
- 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
- Spinal cord compression or brain metastases (unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 2 weeks prior to the first dose of study intervention). Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure). A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and the first dose of study intervention. A minimum of 3 days must have elapsed between the end of corticosteroid therapy for CNS metastatic disease and the first dose of study intervention.
- Leptomeningeal carcinomatosis or metastasis.
See the full eligibility criteria
Who can join
- 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 including HER2 null with no staining or incomplete and faint/barely perceptible membrane staining in ≤ 10% of tumour cells) based on a fresh, or recent tissue sample obtained no more than 6 weeks prior to or during the screening period.
- Progressed on and/or not suitable for further endocrine-based 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 (newly acquired tumour biopsy at baseline or a tumour biopsy sample collected within 6 weeks prior to screening)
- 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.
- Not a candidate for T-DXd, defined as: (a) Participants whose tumours are HER2 IHC 0 with no membrane staining observed (b) Participants whose tumours are HER2-ultralow (IHC 0 with membrane staining that is incomplete and is faint/barely perceptible and in ≤ 10% of tumour cells) and have: (i) comorbidities precluding treatment with T-DXd, or (ii) no access to T-DXd (participant’s country has no regulatory access or no reimbursement at the time of screening)
What rules you out
- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases and ongoing or active infection), 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.
- Has clinically severe pulmonary function compromise (ie, requiring any supplemental oxygen), resulting from intercurrent pulmonary illnesses including but not limited to the following: (a) Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial enrolment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc) (b) Any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis, etc) (c) Prior pneumonectomy
- 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
- Spinal cord compression or brain metastases (unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 2 weeks prior to the first dose of study intervention). Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure). A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and the first dose of study intervention. A minimum of 3 days must have elapsed between the end of corticosteroid therapy for CNS metastatic disease and the first dose of study intervention.
- Leptomeningeal carcinomatosis or metastasis.
- Active or uncontrolled hepatitis B or C virus infection
- Known HIV infection that is not well controlled
- Clinically significant corneal disease
- History of non-infectious ILD/pneumonitis, including radiation pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
The study team makes the final eligibility decision.
Where it's taking place
- United States
- China
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; China; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.