Biweekly 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.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Docetaxel

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Centro Universitario Contra El Cancer
    • Monterrey, Nuevo León, Mexico, 64460
      • Jesus Livio Jimenez Santos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: evaluating the response rate and progression-free interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free interval	more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
partial response	Decreases measurable tumor mass by 50% after treatment, With the report of Decreased size in millimeters of the original tumor.	2 months
rate response	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.	3 months

Collaborators and Investigators

• Sponsor: Centro Universitario contra el Cáncer
• Investigators: Principal Investigator: Jesús L Santos, doctor, Centro Universitario contra el Cáncer U.A.N.L.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 18, 2014
• First Submitted That Met QC Criteria: January 18, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: metastatic breast cancer; taxanes; heavily pretreated
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: ON13-004