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New treatment option for Breast Cancer
Official title TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC
ClinicalTrials.gov ID: NCT07074106
What this study is testing
What is Carboplatin and a Taxane?
Carboplatin and a Taxane is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer. The treatment is adjusted based on signs from the immune system (called tumor-infiltrating lymphocytes, or TILs) and imaging results during treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed primary invasive breast carcinoma.
- One of the following conditions:
- Clinical stage T1c N0 M0 with any level of TILs; or
- Clinical stage T2 N0 M0 with TILs ≥ 50%.
- Estrogen receptor (ER) and progesterone receptor (PR) expression \< 10%.
You likely can't join if
- The subject has an uncontrolled severe concomitant condition, including but not limited to: active or ongoing infection, unstable angina...
- Pregnant or breastfeeding participants.
- History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.
See the full eligibility criteria
- Histologically confirmed primary invasive breast carcinoma.
- One of the following conditions:
- Clinical stage T1c N0 M0 with any level of TILs; or
- Clinical stage T2 N0 M0 with TILs ≥ 50%.
- Estrogen receptor (ER) and progesterone receptor (PR) expression \< 10%.
- HER2-negative or non-amplified, according to current ASCO-CAP criteria.
- No evidence of distant metastasis based on imaging performed prior to study entry (chest/abdomen/pelvis CT scan or FDG PET-CT).
- Age ≥ 18 years.
- ECOG performance status of 0 to 2.
- Adequate organ function
- The subject has an uncontrolled severe concomitant condition, including but not limited to: active or ongoing infection, unstable angina, uncontrolled cardiac arrhythmia, congestive heart failure (NYHA Class III or IV)...
- Pregnant or breastfeeding participants.
- History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.
The study team makes the final eligibility decision.
Where it's taking place
- Brasília, Brazil
- Curitiba, Brazil
- Rio de Janeiro, Brazil
- Salvador, Brazil
- São Paulo, Brazil
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brasília, Brazil; Curitiba, Brazil; Rio de Janeiro, Brazil; Salvador, Brazil; São Paulo, Brazil. 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 ClinicalTrials.gov; the study team decides eligibility.