Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02041351
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.
Study:
NCT02041351
Study Brief:
Protocol Section:
NCT02041351