Clinical trial NCT02041351: Biweekly Docetaxel in Patients With Metastatic Breast Cancer.
Official title: Docetaxel in Patients With Metastatic Breast Cancer Who Have Been Heavily Pretreated, Including Prior Treatment With Paclitaxel or Docetaxel.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: metastatic breast cancer
taxanes
heavily pretreated
Lead sponsor: Centro Universitario contra el Cáncer
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 17
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: disease free interval
timeFrame: 4 months
Secondary outcomes:
measure: partial response
timeFrame: 2 months
measure: rate response
timeFrame: 3 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Centro Universitario Contra El Cáncer
state: Nuevo León
city: Monterrey
country: Mexico
facility: Jesus Livio Jimenez Santos
state: Nuevo León
Study officials:
affiliation: Centro Universitario contra el Cáncer U.A.N.L.
name: Jesús L Santos, doctor
role: PRINCIPAL_INVESTIGATOR
References: