Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating… (NCT01525966) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
United States67 participantsStarted 2012-02-15
Plain-language summary
This phase II trial studies how well carboplatin and nab-paclitaxel before surgery work in treating patients with triple negative breast cancer that is inflammatory or has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Who can participate
Age range
19 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be diagnosed with locally advanced (T2 and higher with or without lymph node involvement), and/or inflammatory triple negative breast cancer
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
* Tumor negative for expression of hormone receptors (\< 10%) and not over-expressing HER2 by immunohistochemistry (IHC) (0-1), or in case of IHC of 2, negative by fluorescence in situ hybridization (FISH) or by alternative gene testing
* Bilirubin =\< 1.5 mg/dL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2 x upper limit of normal
* Alkaline phosphatase =\< 2 x upper limit of normal
* Platelets \>= 100,000 cells/mm\^3
* Hemoglobin \> 9.0 g/dL
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
* Creatinine =\< 1.5 mg/dL is recommended; however, institutional norms are acceptable
* Left ventricular ejection fraction \> 50%
* Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
* Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test screening for patients of childb…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial combining carboplatin with nab-paclitaxel before surgery — what does being in Phase 2 mean for how much is already known about the safety and effectiveness of this specific combination for triple-negative breast cancer?
2The trial is measuring whether patients achieve a 'pathological complete response,' meaning no cancer is found at surgery — how likely is that outcome with this regimen compared to what I might expect from standard neoadjuvant chemotherapy?
3Since the trial is active but no longer enrolling new patients, does that mean results or safety data may be available soon, and could that information help us decide whether this approach makes sense for my situation?
4This trial is specifically for triple-negative breast cancer, including inflammatory breast cancer — given my exact diagnosis and stage, would you consider me a good candidate for a similar chemotherapy approach, either within or outside of a clinical trial?
5The trial also measures 'Residual Cancer Burden' after treatment, which reflects how much cancer remains at surgery — what does that measurement mean for my longer-term prognosis, and how would my care team use that information to plan next steps?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pCR Rate After Treatment.
Timeframe: At completion of definitive surgery, up to six months from initial treatment
2
Residual Cancer Burden (RCB) by Symmans Criteria.
Timeframe: At completion of definitive surgery, up to six months post-commencement of study chemotherapy.