Biweekly Docetaxel in Patients With Metastatic Breast Cancer.

NCT ID: NCT02041351

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

docetaxel

measurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

evaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy

Interventions

Docetaxel

evaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy

Intervention Type: DRUG

Other Intervention Names

evaluating the response rate and progression-free interval

Eligibility Criteria

Exclusion Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centro Universitario contra el Cáncer

OTHER

Sponsor Role: lead

Responsible Party

Jesus Livio Jimenez Santos

medical oncology resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesús L Santos, doctor

Role: PRINCIPAL_INVESTIGATOR

Centro Universitario contra el Cáncer U.A.N.L.

Locations

Centro Universitario Contra El Cáncer

Monterrey, Nuevo León, Mexico

Jesus Livio Jimenez Santos

Monterrey, Nuevo León, Mexico

Countries

Mexico

Other Identifiers

ON13-004

Identifier Type: -

Identifier Source: org_study_id