Metastatic Breast CancerPhase 2NCT02041351
Biweekly Docetaxel in Patients With Metastatic Breast Cancer.
A Phase 2 study testing Docetaxel in people with Metastatic Breast Cancer, run by Centro Universitario contra el Cáncer at 2 sites in Mexico.
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… Read more about this study
- Who is it for?
- Ages 21 to 85 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesMexico
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Centro Universitario Contra El Cáncer
Monterrey, Nuevo León, 64460
Jesus Livio Jimenez Santos
Monterrey, Nuevo León, 64460
About this study
Official title: 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.
Read the 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
- Response tumor shrinkage by royalty over 30%.
- Greater than 1 cm in the size of tumor lesions decrease.
- Disease-free survival
- Progression-free survival.
- Stable disease
- Improved quality of life that is decreased bone pain, improvement of dyspnea.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Docetaxel
- Keywords
- metastatic breast cancer, taxanes, heavily pretreated
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called evaluating the response rate and progression-free interval
evaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| docetaxel | Experimental | measurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free interval
more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed
Measured: 4 months
Secondary outcomes (2)
partial response
Decreases measurable tumor mass by 50% after treatment, With the report of Decreased size in millimeters of the original tumor.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario contra el Cáncer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Livio Jimenez Santos, Centro Universitario contra el Cáncer
- Investigators
- Jesús L Santos, doctor, Principal investigator, Centro Universitario contra el Cáncer U.A.N.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041351
- Sponsor's protocol ID
- ON13-004
- Status last verified
- Jan 2016
- First submitted
- 18 Jan 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel in Patients With Metastatic Breast Cancer Who Have Been Heavily Pretreated, Including Prior Treatment With Paclitaxel or Docetaxel.
- ClinicalTrials.gov ID
- NCT02041351
- Acronym / sponsor ID
- ON13-004
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic breast cancer, taxanes, heavily pretreated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centro Universitario contra el CáncerUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Response tumor shrinkage by royalty over 30%.
- Greater than 1 cm in the size of tumor lesions decrease.
- Disease-free survival
- Progression-free survival.
- Stable disease
- Improved quality of life that is decreased bone pain, improvement of dyspnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| docetaxel | Experimental | Drug: Docetaxelmeasurement evaluation every 2 months tomography of all measurable lesions in millimeters, to assess response rate, partial and complete responses. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: evaluating the response rate and progression-free intervalevaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy | Drug | docetaxel |
Primary outcome
disease free interval
Time frame: 4 months
more than 4 months free of clinically detectable cancer until recurrent cancer is diagnosed
2 secondary outcomes
partial response
Time frame: 2 months
rate response
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús L Santos, doctor principal investigator
Centro Universitario contra el Cáncer U.A.N.L.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel in people with Metastatic Breast Cancer, run by Centro Universitario contra el Cáncer at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free interval (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.