Study on [177Lu]Lu-NeoB and Capecitabine for Treating Advanced Breast Cancer
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT06247995
This clinical trial is testing a new treatment combining [177Lu]Lu-NeoB and capecitabine for patients with advanced breast cancer that has not responded to previous therapies. The study aims to find the best dose and evaluate the treatment's effectiveness.
Patient Parameters
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Program Overview
The study is exploring a new treatment for patients with advanced breast cancer that has spread and is not responding to standard treatments. It involves using a combination of [177Lu]Lu-NeoB, a targeted therapy, and capecitabine, a chemotherapy drug. The trial is divided into two parts: Phase I will determine the safest and most effective doses, while Phase II will assess how well the treatment works at different doses. Participants will undergo regular imaging tests and health assessments to monitor their response to the treatment.
Description
This study is designed to find the best way to use a new treatment for advanced breast cancer that has spread and is not responding to other treatments. The treatment combines [177Lu]Lu-NeoB, which targets specific cancer cells, with capecitabine, a chemotherapy drug.
In Phase I, researchers will test different doses to find the safest and most effective one. In Phase II, they will evaluate how well the treatment works at these doses. Participants will receive regular imaging tests to track the cancer's response and will be monitored for side effects.
The study will include up to 58 participants, who will receive the treatment every three weeks for up to 18 months, with follow-up visits for up to five years. Participants will need to meet specific health criteria and agree to regular health checks and imaging tests.
The study aims to provide a new treatment option for patients with advanced breast cancer that has not responded to other therapies, offering hope for better outcomes.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of estrogen receptor-positive (ER+), HER2-negative breast cancer.
- Have advanced breast cancer that has spread and progressed after previous treatments, including at least one with a CDK4/6 inhibitor.
- Have measurable cancer that can be tracked using imaging tests.
- Have good overall health and organ function as determined by specific blood tests.
- Be able to swallow capecitabine tablets.
- For Phase I: Female participants must be postmenopausal.
- For Phase II: Female participants can be pre-, peri-, or postmenopausal.
Exclusion Criteria
- Have severe or uncontrolled medical conditions that could pose safety risks.
- Have received more than one prior chemotherapy or antibody-drug conjugate treatment for advanced cancer.
- Have had major surgery within 14 days before starting the study treatment.
- Have a history of severe allergic reactions to the study drugs.
- Have other active cancers or have had another cancer within the past three years, except for certain skin or cervical cancers.
- Have gastrointestinal issues that could affect the absorption of the study drugs.
- Have significant heart problems or uncontrolled high blood pressure.
- Are pregnant or breastfeeding, or not using effective contraception if of childbearing potential.
- Are currently participating in another clinical trial or have taken investigational drugs recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| Uni Of TX MD Anderson Cancer Cntr | 77030 | Houston | Texas |
| University Of Wisconsin | 53792 | Madison | Wisconsin |
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