Authorised Therapeutic use (Phase IV) ER+ HER2- Breast cancer

SPatial Heterogeneity of INtratumoral drug distribution

Q: 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.

Q: 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.

Q: 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.

Q: Who can join this trial?

This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.

EU CTIS ID: 2025-520530-32-00

What this study is testing

Determine the spatial distribution of Aromatase Inhibitor and CDK4/6 inhibitor (ribociclib) in ER+ HER2- early breast cancer in postmenopausal patients scheduled to undergo upfront surgery for their tumor.

Therapeutic use (Phase IV)

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

1.Adult postmenopausal women (≥ 18 years of age). Men will not be able to participate as there is no registration for treatment with aromatase inhibition in early breast cancer. 2.Pathologically proven diagnosis of adenocarcinoma of the breast with clinical stage I-IIa (clinical stage T1c-T2N0; tumors of 1.5-5 cm) scheduled for upfront surgery 3.Documentation of histologically confirmed diagnosis breast cancer with ER expression ≥10% and HER2 negative according to standard procedures based on local results. 4.Good performance status, ECOG>2 5. Good organ function. 6.Able to give written informed consent and to comply with the SPHINX protocol.

You likely can't join if

1.Contra-indication for aromatase inhibitors (AI). 2.Contra-indication for ribociclib a. Prolonged QTc time of ≥ 450 ms b. Allergy to peanuts/soja (coating ribocliclib tablets) 3.Contra-indication for MRI imaging. 4. Contra-indications for US contrast agent 5. Prior endocrine therapy or chemotherapy for breast cancer 6.Use of hormone replacement therapy 7.Patients should have no other current malignancy except squamous cell skin cancer of basal cell skin cancer. 8.Patients cannot have had exposure <12 months to the use of AI and/or CDK4/6 inhibitors.

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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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.