Breast CancerPhase 2NCT00721747
Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast Cancer
A Phase 2 study testing Docetaxel, Liposomal doxorubicine and Cyclophosphamide in people with Breast Cancer, run by Grupo Oncológico Gallego at 6 sites in Spain.
Trial summary
The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel, Liposomal doxorubicine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 6 sitesSpain
- Study dates
- Jan 2008to Jan 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Brest adenocarcinoma stages II/III
- Female
- Informed consent signed
- HER2 negative
- Age>18 years old
- ECOG < 1
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- Proper organic function regarding the following criteria:
- ANC > 2,0 x 109L, platelets > 100 x 109L and hemoglobin > 10g/dL (transfusion is allowed)
- Hepatic Function:
- i.Bilirubin < 1,5 x UNL ii.AST ,ALT < 2,5 x UNL iii.Alkaline phosphatase < 5 UNL iv.Patients with AST and /or ALT > 1.5 x UNL and alkaline phosphatase > 2.5 x UNL will not be selected for the study c.Renal function: creatinine < 1,25 x UNL, or creatinine clearance > 60 mL/min d.Normal Cardiac function, confirmed with FEVI >50% and electrocardiogram.
- Patients should be available for treatment and follow up and must be treated in investigator or co-investigator site
- Negative pregnancy test(performed 7 days before treatment)
Who cannot join
- Previous treatment for breast cancer (CT, RT, IT, HT)
- Stages IIIb, IIIc or IV or invasive bilateral breast cancer
- Previous neoplasias treated with Anthracyclines or Taxanes (Paclitaxel or Docetaxel)
- Pregnant or breastfeeding females
- Neurotoxicity Grade 2
- FEV≤50% or any cardiac disease in which anthracyclines are contraindicated
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- Other severe diseases regarding investigator criteria
- Any neurological or psychiatric pathology
- Previous neoplasia different from breast cancer except:
- skin cancer(no melanoma)
- In situ cervix Carcinoma
- Ipsilateral in situ ductal carcinoma
- In situ lobular in situ carcinoma
- Any other carcinoma without evidence disease in last 10 years
- Treatment chronic with corticoids (except patients starting 6 months before inclusion with low dosages (* 20 mg methylprednisolone or equivalent)
- Concomitant treatment with Hormone ovarian replacement therapy
- Contraindication for corticoids
- Concomitant treatment with another investigational drugs
- Included in another clinical trial with any drug in 30 days before inclusion study
- Concomitant treatment with another anticancer therapy
- Male patients
- Hypersensibility to any study drug or components
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Juan Canalejo
A Coruña, Galicia, 15006
Centro Oncológico de Galicia
A Coruña, Galicia, 15009
Hospital de Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08906
Complejo Hospitalario de Ourense
Ourense, Galicia, 32005
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, 15706
Hospital Xeral Cies
Vigo, Galicia, 36204
About this study
Official title: Phase II, Open, Not Randomized Clinical Trial, to Evaluate the Sequential Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in her2 Negative Breast Cancer Patients
The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.
Read the detailed description
Phase II, open, not randomized clinical trial, to evaluate the sequential Taxotere®, followed by Myocet® and Cyclophosphamide first line treatment in her2 negative breast cancer patients.
The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Liposomal doxorubicine and Cyclophosphamide
- Keywords
- breast cancer patients her2 negative pathological responses
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, Liposomal doxorubicine and CyclophosphamideDrug
4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv
| Study group | Role | What they receive |
|---|---|---|
| Unique arm | Experimental | 4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv Receives: Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine proportion of Pathological complete responses
Measured: At the end of the treatment, after Surgery.
Secondary outcomes (6)
Determine proportion of clinical responses
Measured: At the end of the treatment
Describe treatment safety
Measured: At the end of the treatment
Determine proportion of conservative breast surgery
Measured: At the end of the study
Evaluate disease free survival
Measured: At the end of the treatment
Evaluate Overall survival
Measured: At the end of the treatment
Evaluate gene patterns regarding prediction of treatment response
Measured: At the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2011
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Oncológico Gallego
- Sponsor type
- University, hospital or other
- Collaborators
- Pivotal S.L.
- Responsible party
- Sponsor
- Investigators
- Jesús García Mata, MD, Principal investigator, Grupo Oncológico Gallego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721747
- Sponsor's protocol ID
- GOG/2007-01
- Other IDs
- 2007-005173-56
- Status last verified
- Mar 2012
- First submitted
- 23 Jul 2008
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open, Not Randomized Clinical Trial, to Evaluate the Sequential Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in her2 Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00721747
- Acronym / sponsor ID
- GOG/2007-01
- Conditions
- Breast Cancer
- Keywords
- breast cancer patients her2 negative pathological responses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Grupo Oncológico GallegoUniversity, hospital or other
- Collaborators
- Pivotal S.L.
- Study start
- Jan 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2015 (estimated)
- First posted
- 24 Jul 2008 (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.
The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.
Detailed description
Phase II, open, not randomized clinical trial, to evaluate the sequential Taxotere®, followed by Myocet® and Cyclophosphamide first line treatment in her2 negative breast cancer patients.
The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unique arm | Experimental | Drug: Docetaxel, Liposomal doxorubicine and Cyclophosphamide4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Brest adenocarcinoma stages II/III
- Female
- Informed consent signed
- HER2 negative
- Age>18 years old
Key exclusion criteria (22 listed)
- Previous treatment for breast cancer (CT, RT, IT, HT)
- Stages IIIb, IIIc or IV or invasive bilateral breast cancer
- Previous neoplasias treated with Anthracyclines or Taxanes (Paclitaxel or Docetaxel)
- Pregnant or breastfeeding females
- Neurotoxicity Grade 2
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 |
|---|---|---|
| Docetaxel, Liposomal doxorubicine and Cyclophosphamide4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv | Drug | Unique arm |
Primary outcome
Determine proportion of Pathological complete responses
Time frame: At the end of the treatment, after Surgery.
6 secondary outcomes
Determine proportion of clinical responses
Time frame: At the end of the treatment
Describe treatment safety
Time frame: At the end of the treatment
Determine proportion of conservative breast surgery
Time frame: At the end of the study
Evaluate disease free survival
Time frame: At the end of the treatment
Evaluate Overall survival
Time frame: At the end of the treatment
Evaluate gene patterns regarding prediction of treatment response
Time frame: At the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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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 García Mata, MD principal investigator
Grupo Oncológico Gallego
6 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, Liposomal doxorubicine and Cyclophosphamide in people with Breast Cancer, run by Grupo Oncológico Gallego at 6 sites in Spain.
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 12 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
Results are not available in the source record.
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?
Determine proportion of Pathological complete responses (time frame: At the end of the treatment, after Surgery.). 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 16 Mar 2012.