A PHASE II PROSPECTIVE TRIAL CORRELATING THE PROGRESSION FREE SURVIVAL CYP2D6 WITH ACTIVITY IN PATIENTS WITH METASTATIC BREAST CANCER TREATED WITH SINGLE AGENT TAMOXIFE
- Conditions
- -C61 Malignant neoplasm of prostateMalignant neoplasm of prostateC61
- Registration Number
- PER-114-10
- Lead Sponsor
- EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG), GRUPO DE ESTUDIOS CLINICOS ONCOLOGICO DEL PERU GECOPERU,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 37
• You must have breast adenocarcinoma with positive estrogen and / or progesterone receptors histologically confirmed.
• Patients must have measurable or non-measurable stage III / locally advanced or metastatic breast carcinoma where surgery is not possible, as defined in Section 6.1.1. Injuries must be evaluated within 4 weeks prior to registration.
• Age> 18 years.
• Fertile women and sexually active men should be strongly advised to use an accepted and effective method of non-hormonal contraception. The acceptable contraceptive method includes barrier methods (eg, condoms or diaphragm) or intra uterine devices or IUDs (these may include low doses of hormones at the discretion of the Study Directorate).
• ECOG functional status assessment of 0-2.
• Patients with a history of central nervous system metastases are allowed since they have been treated (surgery, radiation or radiosurgery) at least 4 weeks prior to starting the study drug and do not require medication (s) to control the symptoms. Patients with leptomeningeal disease are not eligible.
• Patients may receive concurrent radiotherapy at sites with bone disease pain or areas of impending fracture as long as radiation therapy is initiated prior to study entry and sites of measurable and non-measurable disease outside of port radiotherapy are available for follow-up. . Patients who have received previous radiation therapy must have recovered from the toxicity of previous radiation therapy.
• Women should not be pregnant or breastfeeding due to the harmful effects of Tamoxifen.
• The patient should not have received chemotherapy or Trastuzumab (Herceptin) for metastatic disease. Chemotherapy or Trastuzumab or Bevacizumab in adjuvant therapy is allowed but must have been completed at least 6 weeks before starting the study. Research agents prior to metastatic treatment are not allowed. Previous investigating agents in adjuvant treatment should be discussed with the Principal Investigator of the study.
• Prior Tamoxifen or other agents that modulate or decrease the regulation of estrogen receptors (eg Raloxifene, Fulvestrant) are not allowed. Previous aromatase inhibitor (up to 2 agents) (eg Anastrozole, Letrozole, Exemestane, Aminoglutetamide) is allowed in adjuvant or metastatic management.
• Concurrent hormone therapy that is not part of the protocol is not allowed.
• Concurrent chemotherapy is not allowed.
• Patients should not take the following medications that are strong to moderate CYP2D6 inhibitors and may alter the metabolism of Tamoxifen: Paroxetine (Paxil), Fluoxetine (Prozac), Buproprion (Wellbutrin) and quindine (Cardioquin) within 2 weeks from the register.
• Patients must not have suffered from medical or psychiatric conditions that may interfere with the conformity of the protocol, the ability to give informed consent, or the evaluation of the response or anticipated toxicities.
• Patients should be free of disease from previous invasive malignancies for> 5 years with the exception of basal cell skin carcinoma or squamous cell treated with curative intent or carcinoma in situ of the cervix.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Only those patients who have measurable disease present at the beginning, have received at least one cycle of therapy, and have had re-evaluation of their disease will be considered evaluable for the response. These patients will have their response classified according to the definitions set out below. (Note: Patients who exhibit progression of objective disease prior to the end of cycle 1 are also considered evaluable.)<br>Measure:Objective Response Evaluation<br>Timepoints:During the study<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Measurable lesions are defined as those that can be measured precisely in at least one dimension (the largest diameter should be filed) of> 20mm by chest x-ray,> 10mm with CT, or> 10mm with calipers by clinical examination. All tumor measurements are archived in millimeters.<br>Measure:Measurable disease<br>Timepoints:During the study<br>;<br>Outcome name:All other lesions (or disease sites), including small lesions (larger diameter <10 mm or pathological lymph nodes with short axes if O at <15 mm), are considered non-measurable disease. Bone lesions, ieptomeningeal disease, ascites, pleural / pericardial effusions, cutis / pulmonitis lymphangitis, inflammatory breast disease, and abdominal masses (without follow-up by CT or MRI), are considered as not measurable. Non-measurable also include lesions that are <20 mm by chest X-ray.<br>Measure:Non Measurable Diseases<br>Timepoints:During the study<br>