Biweekly Docetaxel in Patients With Metastatic Breast Cancer.
- Registration Number
- NCT02041351
- Lead Sponsor
- Centro Universitario contra el Cáncer
- Brief Summary
There is clinical benefit of docetaxel administered to patients who have progressed to 3 or more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic responses are obtained that it never received taxanes.
- Detailed Description
Methodology:
Prospective non-randomized phase IIa. The selected patients with metastatic breast cancer heavily pretreated including those previously treated with taxanes, receive docetaxel administered at a dose of 45mg/m2 body surface every 2 weeks to assess the activity of this drug.
Variables:
Age. Menopausal status. Hormone receptor status. Overexpression of HER2 neu. Location of metastatic sites. Performance status (PS) 0-3. comorbidities.
Case management in the variables (patient subgroups )
The patients with HER 2 neu overexpression of anti -HER2 therapy will further chemotherapy with docetaxel.
The patients presenting with brain metastases may receive radiation therapy to the brain and then at the end of radiotherapy, start docetaxel.
Patients whose tumors express estrogen receptors and progesterone positive receive treatment with docetaxel:
Where there is visceral crisis and it is shown that they have already progressed to more than 2 lines of previously administered hormone treatment.
In no event cytotoxic chemotherapy with concurrent docetaxel was administered to an anti-estrogen drug.
And they can continue only when hormone therapy has achieved complete response measurable lesions with docetaxel and opt for a non-cytotoxic anti-estrogen therapy and when it came to presenting unacceptable toxicity with docetaxel.
Evaluations:
clinical assessment that will include physical examination and review of laboratory studies were carried out every 2 weeks before authorizing the housing management of a next cycle.
The objective assessment of tumor response was carried out by imaging studies (CT) by RECIST criteria after administration of the 4 criteria of cycles, a cycle is administered every 2 weeks with docetaxel at a dose of 45mg/m2.
Response Criteria
1. Response tumor shrinkage by royalty over 30%.
2. Greater than 1 cm in the size of tumor lesions decrease.
3. Disease-free survival
4. Progression-free survival.
5. Stable disease
6. Improved quality of life that is decreased bone pain, improvement of dyspnea.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 17
Women over 21 years of age diagnosed with breast cancer in clinical stage IV, who had received 3 or more lines of cytotoxic chemotherapy, which may have included paclitaxel or docetaxel, which have measurable or evaluable tumor activity in any distant organ and who are fully conscious and well oriented to permit informed consent.
Male patients with metastatic breast cancer. Patients with grade 3 neuropathy by prior exposure to taxanes. Patients under 21 and over 85 years of age. Metastasis of one site in the central nervous system.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description docetaxel Docetaxel measurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses.
- Primary Outcome Measures
Name Time Method disease free interval 4 months more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed
- Secondary Outcome Measures
Name Time Method partial response 2 months Decreases measurable tumor mass by 50% after treatment, With the report of Decreased size in millimeters of the original tumor.
rate response 3 months percentage of patients who responded with a decrease greater than 40% of the lesions at the time of initiation of this treatment after 3 months of treatment.
Trial Locations
- Locations (2)
Jesus Livio Jimenez Santos
🇲🇽Monterrey, Nuevo León, Mexico
Centro Universitario Contra El Cáncer
🇲🇽Monterrey, Nuevo León, Mexico