Docetaxel in Patients With Metastatic Breast Cancer.

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centro Universitario contra el Cáncer
Sponsor:
Information provided by (Responsible Party):
Jesus Livio Jimenez Santos, Centro Universitario contra el Cáncer
ClinicalTrials.gov Identifier:
NCT02041351
First received: January 18, 2014
Last updated: February 22, 2014
Last verified: February 2014

January 18, 2014
February 22, 2014
November 2013
September 2014   (final data collection date for primary outcome measure)
disease free interval [ Time Frame: 4 months ] [ Designated as safety issue: No ]
more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed
Same as current
Complete list of historical versions of study NCT02041351 on ClinicalTrials.gov Archive Site
  • partial response [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Docetaxel in Patients With Metastatic Breast Cancer.
Docetaxel in Patients With Metastatic Breast Cancer Who Have Been Heavily Pretreated, Including Prior Treatment With Paclitaxel or Docetaxel.

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.

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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: Docetaxel
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
Experimental: docetaxel
measurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses.
Intervention: Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
October 2015
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria: 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.

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.

Female
21 Years to 85 Years
No
Contact: Jesús L Santos, Doctor 528115044324 jesuslivio@gmail.com
Contact: José L Gonzalez, Doctor 528183338112 ext 303 josegonzalezvela@hotmail.com
Mexico
 
NCT02041351
ON13-004
Yes
Jesus Livio Jimenez Santos, Centro Universitario contra el Cáncer
Centro Universitario contra el Cáncer
Not Provided
Principal Investigator: Jesús L Santos, doctor Centro Universitario contra el Cáncer U.A.N.L.
Centro Universitario contra el Cáncer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP