Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Biweekly Docetaxel in Patients With Metastatic Breast Cancer.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel in Patients With Metastatic Breast Cancer Who Have Been Heavily Pretreated, Including Prior Treatment With Paclitaxel or Docetaxel.

Resource links provided by NLM:


Further study details as provided by Centro Universitario contra el Cáncer:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 35
Study Start Date: November 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: docetaxel
measurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses.
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

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.
  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041351

Contacts
Contact: Jesús L Santos, Doctor 528115044324 jesuslivio@gmail.com
Contact: José L Gonzalez, Doctor 528183338112 ext 303 josegonzalezvela@hotmail.com

Locations
Mexico
Centro Universitario Contra El Cáncer Recruiting
Monterrey, Nuevo León, Mexico, 64460
Contact: Jesús L Santos, investigator    528115044324    jesuslivio@gmail.com   
Contact: Jose L Gonzalez, chief    528183095131    josegonzalezvela@hotmail.com   
Principal Investigator: Jose L Gonzalez, chief         
Sub-Investigator: Jesus L Jimenez, resident         
Jesus Livio Jimenez Santos Recruiting
Monterrey, Nuevo León, Mexico, 64460
Contact: Jose L Gonzalez, chief    5218183095131    josegonzalezvela@hotmail.com   
Sub-Investigator: Jesus L Jimenez, resident         
Sponsors and Collaborators
Centro Universitario contra el Cáncer
Investigators
Principal Investigator: Jesús L Santos, doctor Centro Universitario contra el Cáncer U.A.N.L.
  More Information

No publications provided

Responsible Party: Jesus Livio Jimenez Santos, medical oncology resident, Centro Universitario contra el Cáncer
ClinicalTrials.gov Identifier: NCT02041351     History of Changes
Other Study ID Numbers: ON13-004
Study First Received: January 18, 2014
Last Updated: September 4, 2014
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Centro Universitario contra el Cáncer:
metastatic breast cancer
taxanes
heavily pretreated

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 19, 2014