BridgeMD
A multicenter, multicohort, phase 2 platform trial to personalize second-line treatment intensity and targeting in HR-positive, HER2-negative metastatic breast cancer through an integrated liquid biopsy algorithm.
EU CTIS ID: 2025-523460-21-00
What this study is testing
Evaluation of a biomarker driven workflow for guiding clinical decision making in second line HR+/HER2- metastatic breast cancer
- 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
- Female (both pre- and postmenopausal) patients with histologically confirmed diagnosis of adenocarcinoma of the breast with radiological evidence of metastatic disease
- Women of childbearing potential must have a negative highly sensitive serum or urine pregnancy test within 7 days prior to randomisation.
- Female subjects who are breast feeding should discontinue nursing during protocol treatment
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained, and documented according to the local regulatory requirements
- Estrogen Receptor (ER) and/or Progesteron Receptor (PgR) positive disease confirmed at immunohistochemistry (IHC), as either ER or PR expression ≥ 1%, at the time of metastatic diagnosis. Molecular assessment performed locally on either primary tumor tissue or a biopsy specimen from a metastatic site.
You likely can't join if
- Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Known hypersensitivity reaction to one of the compounds or substances used in this protocol
- Pregnant women are excluded from the study
- Male
- Previous or synchronous diagnosis of HER2-positive or triple-negative breast cancer
- Prior chemotherapy for metastatic disease.
See the full eligibility criteria
Who can join
- Female (both pre- and postmenopausal) patients with histologically confirmed diagnosis of adenocarcinoma of the breast with radiological evidence of metastatic disease
- Women of childbearing potential must have a negative highly sensitive serum or urine pregnancy test within 7 days prior to randomisation.
- Female subjects who are breast feeding should discontinue nursing during protocol treatment
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained, and documented according to the local regulatory requirements
- Estrogen Receptor (ER) and/or Progesteron Receptor (PgR) positive disease confirmed at immunohistochemistry (IHC), as either ER or PR expression ≥ 1%, at the time of metastatic diagnosis. Molecular assessment performed locally on either primary tumor tissue or a biopsy specimen from a metastatic site.
- HER2 negative breast cancer by FISH or IHC (IHC 0, 1+, 2+ and/or FISH HER2: CEP17 ratio < 2.0) at the time of metastatic diagnosis.
- Age at the time of signing the informed consent at least 18 years.
- Disease progression after at least 6 months of first line endocrine therapy with CDK 4/6 inhibitors.
- The patient must have evaluable disease according to RECIST 1.1 (either measurable or non-measurable)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function (kidney, bone marrow and liver)
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of study drugs.
What rules you out
- Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Known hypersensitivity reaction to one of the compounds or substances used in this protocol
- Pregnant women are excluded from the study
- Male
- Previous or synchronous diagnosis of HER2-positive or triple-negative breast cancer
- Prior chemotherapy for metastatic disease.
- Disease progression before 6 months of first line endocrine therapy with CDK 4/6 inhibitors
- Major surgery < 28 days before randomisation
- Any unresolved toxic effect of prior therapies or surgical procedures of Grade ≥ 2 according to Common Terminology Criteria of Adverse Events (CTCAE v5.0), with the exception of alopecia, peripheral neuropathy and other toxicities not considered a safety risk for the participant at investigator’s discretion
- Uncontrolled significant active infections (≥ grade 3 according to CTCAE version 5), including active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency Virus (HIV).
- Uncontrolled intercurrent illness, including psychiatric conditions, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
The study team makes the final eligibility decision.
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 female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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.