Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously U… (NCT01750073) | Clinical Trial Compass
CompletedPhase 2
Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer
United States92 participantsStarted 2012-12-07
Plain-language summary
This phase II trial studies the side effects and how well giving paclitaxel and cyclophosphamide with or without trastuzumab before surgery works in treating patients with previously untreated breast cancer. Drugs used in chemotherapy, such as paclitaxel and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may block tumor growth in different ways by targeting certain cells. Giving combination chemotherapy with or without trastuzumab 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:
* Women with histologically proven invasive breast cancer without distant metastases; a clinical tumor classification of tumor size must be at least 1 cm with or without clinical pathologic evidence of positive nodes
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or magnetic resonance imaging (MRI) images to define specific size and validate complete clinical and pathologic response
* Patients who received radiation therapy \> 5 years ago for malignancies other than breast cancer and whose radiation therapy field is not overlapping with the 20% isodose line of current radiation field are eligible, provided that radiation therapy was completed \> 5 years ago and that there is no evidence of the second malignancy at the time of study entry
* Absolute neutrophil count greater than or equal to 1,500/mcl
* Platelet count equal to or greater than 150,000/mcl
* Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN)
* Total bilirubin equal to or less than 1.5 times the ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times the ULN
* Creatinine less than 1.5 times the ULN
* All included patients must have normal cardiac function as defined by an ejection fraction of \>= 50% and no decrease in wall motion by echocardiogram
* The patient must be aware of the neoplast…
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 was a Phase 2 trial focused heavily on measuring toxicities — side effects — from paclitaxel and cyclophosphamide with or without trastuzumab before surgery. Since the trial has now completed, can you tell me what the toxicity data actually showed, and how that should factor into my own treatment planning?
2The trial enrolled patients with a wide range of breast cancer types, including HER2-positive, triple-negative, and estrogen receptor-positive tumors — can you explain which subgroup my diagnosis fits into, and whether the pathologic complete response rates seen in that specific subgroup are encouraging enough to consider this kind of approach for me?
3Since this study gave chemotherapy before surgery rather than after, what are the potential advantages and risks of that sequencing for someone in my situation, and is that still considered a reasonable approach based on what this trial and other research have found?
4Because this trial is now completed and was Phase 2, meaning it was still primarily assessing safety and early signs of effectiveness rather than confirming benefit, is there a larger Phase 3 trial or an established standard-of-care regimen I should be comparing this approach against before making any decisions?
5Trastuzumab was only part of the regimen for some patients in this trial — given my specific HER2 status, would my doctor expect me to receive it or not, and how does that affect what we know about likely outcomes and risks for someone like me?
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
Overall Incidence of Toxicities, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Timeframe: Up to 30 days after completion of study treatment, maximum of 114 days
2
Overall Severity of Toxicities, Graded According to the NCI CTCAE Version 4.0
Timeframe: Up to 30 days after completion of study treatment, maximum of 114 days
3
Number of Participants in the Subgroups Who Had a Pathologic Complete Response (pCR)
Timeframe: Up to 12 weeks (after the first 6 courses of treatment), maximum of 168 days