Biweekly Docetaxel in Patients With Metastatic Breast Cancer.
|ClinicalTrials.gov Identifier: NCT02041351|
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : January 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Docetaxel||Phase 2|
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.
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.
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 tumor shrinkage by royalty over 30%.
- Greater than 1 cm in the size of tumor lesions decrease.
- Disease-free survival
- Progression-free survival.
- Stable disease
- Improved quality of life that is decreased bone pain, improvement of dyspnea.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Docetaxel in Patients With Metastatic Breast Cancer Who Have Been Heavily Pretreated, Including Prior Treatment With Paclitaxel or Docetaxel.|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||December 2015|
measurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses.
evaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy
Other Name: evaluating the response rate and progression-free interval
- disease free interval [ Time Frame: 4 months ]more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed
- partial response [ Time Frame: 2 months ]Decreases measurable tumor mass by 50% after treatment, With the report of Decreased size in millimeters of the original tumor.
- rate response [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041351
|Centro Universitario Contra El Cáncer|
|Monterrey, Nuevo León, Mexico, 64460|
|Jesus Livio Jimenez Santos|
|Monterrey, Nuevo León, Mexico, 64460|
|Principal Investigator:||Jesús L Santos, doctor||Centro Universitario contra el Cáncer U.A.N.L.|