Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients

Launched by KAROLINSKA UNIVERSITY HOSPITAL · Nov 24, 2008

Keywords

ClinConnect Summary

The Panther clinical trial is studying two different treatment approaches for women with breast cancer who are at high risk of their cancer coming back after surgery. One group of patients will receive a personalized chemotherapy plan that involves taking certain medications every two weeks, while the other group will receive a standard chemotherapy treatment given every three weeks. The main goal of this study is to see which treatment helps keep patients cancer-free for a longer time after their initial treatment. Researchers will also look at other important factors, such as overall survival rates and quality of life, throughout the study.

To be eligible for this trial, participants need to be women aged 18 to 65 with confirmed breast cancer that has spread to at least one lymph node, or larger tumors without lymph node involvement. They must have had surgery to remove the cancer and have clear margins, meaning no cancer cells are seen at the edges of the removed tissue. Patients who have received other treatments for breast cancer or have certain health conditions may not qualify. If you join the trial, you can expect to be followed for several years to monitor your health and any potential side effects from the treatments. This study is important because it aims to find the most effective way to reduce the risk of breast cancer returning, ultimately helping improve treatment options for patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Histological proven invasive primary breast cancer, with at least 5 (recommended 10) removed axillary lymph nodes OR negative sentinel node biopsy performed for the node negative cohort. Interval between definitive surgery that includes axillary lymph node dissection and registration must be less than 60 days. Paraffin block from the primary tumour must be retained (not mandatory for Austrian sites). Frozen tumour tissue is strongly recommended to be stored.
• • Receptor negative or positive tumours with 1 or more positive axillary lymph nodes (more than 0.2 mm) OR axillary node negative breast cancers if the primary tumour is larger than 20 mm and receptor negative (Er and Pgr with no receptor content) and being Elston grade III. In Germany high risk node negative breast cancer patients are not eligible until labelling for docetaxel includes node-negative disease.
• • A primary breast cancer patient being 35 years or younger considered suitable for adjuvant chemotherapy (may be receptor negative or positive, HER-2/neu negative or positive, with or without axillary lymph node metastases).
• • Macroscopically and microscopically free margins after radical surgery (no cancer cells at borders of resection).
• • No proven distant metastases (negative chest/pulmonary X-ray, bone scintigram (when clinical signs of skeletal metastases or elevated ALP) supplemented with normal conventional X-ray of hot spots, normal liver function test and haematological function tests; when abnormal values, CT or ultrasound of the liver, patient can be included if no metastases are demonstrated.
• • Female age 18-65.
• • Ambulant patients (ECOG 1 or less).
• • No major cardiovascular morbidity NYHA I or II. (Appendix 3).
• • Written informed consent according to the local ethics committee requirements.
• • Patients of childbearing potential should have a negative pregnancy test within seven days of registration. (In Austria, pregnancy tests have to be repeated monthly during the treatment phase).
• Exclusion Criteria:
• • Previous neo-adjuvant treatment.
• • Non-radical surgery (histopathological positive margins).
• • Proven distant metastases.
• • Pregnancy or lactation.
• • Other serious medical condition.
• • Previous or concurrent malignancies at other sites, except basal cell carcinoma and/or squamous cell carcinoma in situ of the skin or cervix. Patients with previous breast cancer (invasive and/or ductal carcinoma in situ) in the other breast without loco-regional (large lung volumes) radiotherapy, without objective findings for relapse, with \> 5 years since diagnosis can be included.
• • Abnormal laboratory values precluding the possibility to safely deliver the used cytotoxic agents in the study.
• • Hypersensitivity to drugs formulated in polysorbate 80.
• • Peripheral neuropathy grade ≥2.