Biweekly Docetaxel in Patients With Metastatic Breast Cancer.

Metastatic Breast Cancer Clinical Trial

Official title:

Docetaxel in Patients With Metastatic Breast Cancer Who Have Been Heavily Pretreated, Including Prior Treatment With Paclitaxel or Docetaxel.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041351
• Other study ID #: ON13-004
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2014
• Last updated: January 26, 2016
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Centro Universitario contra el Cáncer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Docetaxel
evaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy

Locations

Country	Name	City	State
Mexico	Centro Universitario Contra El Cáncer	Monterrey	Nuevo León
Mexico	Jesus Livio Jimenez Santos	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario contra el Cáncer

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free interval	more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed	4 months	No
Secondary	partial response	Decreases measurable tumor mass by 50% after treatment, With the report of Decreased size in millimeters of the original tumor.	2 months	No
Secondary	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	No