Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response (NCT02280252) | Clinical Trial Compass
CompletedPhase 2
Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response
United States69 participantsStarted 2005-03
Plain-language summary
The need to understand LABC is especially compelling in populations and countries with limited resources, where breast cancer incidence is relatively low, but mortality is comparably high. In these settings access to appropriate cancer care is characteristically limited or often plainly nonexistent. In contrast to economically developed nations, where on average fewer than 20% of women present with breast cancer at advanced stages, LABC and metastatic disease are the most common stages at presentation in 50% or more women in Latin America, Asia and Africa.
Who can participate
Age range
18 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:
* Biopsy proven locally-advanced breast cancer: IIB, IIIA, and IIIB
* Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes
* Measureable disease required
* Adequate laboratory values:
Hgb \> 10 ANC \> 1500 Platelets \> 150,000 Creatinine \< 1.5 Liver function \< 3x normal
* Patient ≥ 18 years of age
* Medically and psychologically able to comply with all study requirements
* ECOG performance score 0-1
* CT chest, abdomen, and pelvis performed
* Mammogram or USG performed
* Signed informed consent
Exclusion Criteria:
* Breast cancer patients with Stage 0, Stage I, or Stage IIA
* Previous XRT or chemotherapy
* Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes
* Pregnancy
* Inflammatory breast cancer
* Patients under treatment (or who will have recently been treated) with anti-neoplastic, immunosuppressive or hormonal medications
* Patients who are found to have a cancer positive for the marker HER-2/neu (applies only to NYU Tisch and Bellevue sites)
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort