Locally Advanced HER2-negative Breast CancerPhase 2TAME-01NCT01329627
Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer
A Phase 2 study testing Paclitaxel/doxorubicin/cyclophosphamide in people with Locally Advanced HER2-negative Breast Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced HER2-negative Breast Cancer
- What is being tested?
- Paclitaxel/doxorubicin/cyclophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Aug 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced breast cancer diagnosed by guided core biopsy
- T > 2 cm (any N), or any T and node positive (needle biopsy is required)
- Non-metastatic disease assessed by computed tomography and bone scintigraphy
- Histological grade 2 and Ki67 > 15% or
- Histological grade 3 or
- Any triple negative (TN) or
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- Inflammatory breast cancer (IBC)
- Normal left ventricular ejection fraction (LVEF)
- HER2-negative disease
Who cannot join
- Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
- Clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
- LVEF value below institutional limits of normal
- Predominant lobular carcinoma histology
- Grade 1 tumors
- Detected or suspicious distant metastasis
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- Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN
- Male sex
- HER2-positive breast cancer
Trial locations and contacts
1 site in 1 country.
Brazil1 site
State of Sao Paulo Cancer Institute
São Paulo, São Paulo, 01246-000
About this study
Official title: Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer
The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.
- Being tested
- Paclitaxel/doxorubicin/cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel/doxorubicin/cyclophosphamideDrug
Also called Metronomic chemotherapy
Metronomic chemotherapy as described below:
- Paclitaxel 100 mg/m2 once a week for 8 weeks followed by;
- Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.
Paclitaxel/doxorubicin/cyclophosphamideDrug
Also called Metronomic chemotherapy
Metronomic chemotherapy as described below:
Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel/doxorubicin/cyclophosphamide | Experimental | Not described Receives: Drug: Paclitaxel/doxorubicin/cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of febrile neutropenia
Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%
Measured: 18 weeks
Secondary outcomes (1)
Efficacy
Efficacy will be assessed by:
- Tumor measurements using MRI
- Pathologic complete response
- Progression-free survival
- Overall survival
Measured: From the beginning of treatment until surgery, progression and death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionAug 2012
Why it stopped: Toxicity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced HER2-negative 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Faculdade de Medicina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329627
- Sponsor's protocol ID
- NP 50/2010 - TAME
- Acronym
- TAME-01
- Status last verified
- May 2014
- First submitted
- 8 Nov 2010
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Feasibility Study of Weekly Paclitaxel Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide for Locally Advanced HER2-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01329627
- Acronym / sponsor ID
- TAME-01 / NP 50/2010 - TAME
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Toxicity
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Fundação Faculdade de Medicina
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Apr 2011 (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 whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel/doxorubicin/cyclophosphamide | Experimental | Drug: Paclitaxel/doxorubicin/cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Locally advanced breast cancer diagnosed by guided core biopsy
- T > 2 cm (any N), or any T and node positive (needle biopsy is required)
- Non-metastatic disease assessed by computed tomography and bone scintigraphy
- Histological grade 2 and Ki67 > 15% or
- Histological grade 3 or
Key exclusion criteria (9 listed)
- Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
- Clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
- LVEF value below institutional limits of normal
- Predominant lobular carcinoma histology
- Grade 1 tumors
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 |
|---|---|---|
| Paclitaxel/doxorubicin/cyclophosphamideAlso: Metronomic chemotherapyMetronomic chemotherapy as described below: 1. Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; 2. Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks. | Drug | Paclitaxel/doxorubicin/cyclophosphamide |
| Paclitaxel/doxorubicin/cyclophosphamideAlso: Metronomic chemotherapyMetronomic chemotherapy as described below: Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks. | Drug | Paclitaxel/doxorubicin/cyclophosphamide |
Primary outcome
Incidence of febrile neutropenia
Time frame: 18 weeks
Incidence of febrile neutropenia with modified metronomic schedule (whithout GCSF) will be no higher than 10%
1 secondary outcome
Efficacy
Time frame: From the beginning of treatment until surgery, progression and death
Results and safety
The study was stopped early (reason given: Toxicity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel/doxorubicin/cyclophosphamide in people with Locally Advanced HER2-negative Breast Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 was stopped early (reason given: Toxicity). 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?
Incidence of febrile neutropenia (time frame: 18 weeks). 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 21 May 2014.