Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recur… (NCT00346229) | Clinical Trial Compass
TerminatedPhase 1
Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer
Stopped: Funding
United States29 participantsStarted 2006-04
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Giving temperature-sensitive liposomal doxorubicin together with hyperthermia may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temperature-sensitive liposomal doxorubicin when given together with hyperthermia in treating women with locally recurrent breast cancer.
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.
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Locally recurrent disease involving the chest wall and/or its overlying skin
* Clinically and biopsy proven disease on the chest wall area measuring ≥ 1 cm
* Overall surface extent of tumor ≤ two 16 x 16 cm fields
* Tumor thickness ≤ 3 cm by clinical exam and CT scan or MRI
* Disease extent on the chest wall that exceeds the above criteria allowed provided no other local therapies are available
* Patients with axillary disease involvement only must meet the above criteria in order to be eligible
* Prior skin changes consistent with inflammatory breast cancer are allowed
* Distant metastasis (excluding known brain metastases) allowed
* No resectable chest wall recurrence as the only site of metastatic disease
* No refractory pain secondary to metastatic disease
* Must have undergone prior local radiotherapy to the chest wall or breast in the adjuvant or metastatic setting
* Must have progressed on ≥ 1 course of hormonal therapy for metastatic disease (if tumor is estrogen receptor positive or progesterone receptor positive) AND ≥ 1 course of chemotherapy
* Prior contralateral breast malignancy allowed provided not previously treated with chemotherapy
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* Zubrod performance status 0-1 OR Karnofsky performance status 90-100%
* Not pregnant
* Negative pregnan…
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
Maximum tolerated dose of temperature-sensitive liposomal doxorubicin (ThermoDox™) in combination with hyperthermia