Biweekly Docetaxel in Patients With Metastatic Breast Cancer.

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Metastatic Breast Cancer	Drug: Docetaxel	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
Intervention Model:	Single Group Assignment
Masking:	None (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.
Study Start Date :	November 2013
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	December 2015

Arms and Interventions

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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 Name: evaluating the response rate and progression-free interval

Outcome Measures

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Primary Outcome Measures :

1. disease free interval [ Time Frame: 4 months ]
   more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 85 Years (Adult, Older Adult)
Sexes 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

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Locations

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

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

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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
First Posted:	January 22, 2014
Last Update Posted:	January 27, 2016
Last Verified:	January 2016

Keywords provided by Jesus Livio Jimenez Santos, Centro Universitario contra el Cáncer:

metastatic breast cancer; taxanes; heavily pretreated

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Docetaxel	Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action