Breast CancerPhase 2NCT00068341
Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
A Phase 2 study testing trastuzumab, carboplatin and docetaxel in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 4 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- trastuzumab, carboplatin and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2003to Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed infiltrating adenocarcinoma of the breast
- Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.
- No prior radiation to the involved breast
- ECOG (Electrocochleography) performance status 0-2
- Age 18 years to 80 years
- Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and hemoglobin > 9 g/dl
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- All liver function tests < upper limit of normal
- Serum creatinine < 2.0 mg/dl
- Normal left ventricular ejection fraction (LVEF) as determined by MUGA (Multiple Gated Acquisition) scan or echocardiogram
- HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) test. [FISH (+) is HER-2/neu (+)]
- If female of childbearing potential, pregnancy test is negative
- If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study
- Informed consent has been obtained
Who cannot join
- Non-confirmed infiltrating adenocarcinoma breast cancer
- Evidence of metastasis
- Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin
- Prior radiation to the involved breast
- Recent breast cancer drug therapy within last 5 years of any form
- History of allergy to polysorbate or castor oil
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- Ongoing active infection
- Concurrent life-limiting disease with a life expectancy of less than one year
- Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix
- Pregnancy, nursing, fertile women who do not use birth control device
- Inability to give informed consent
- Patients with pre-existing peripheral neuropathy > grade 2
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Wilshire Oncology Medical Group, Incorporated - Pomona
Pomona, California, 91767-3021
About this study
Official title: Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, carboplatin, docetaxel
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
Also called Herceptin
Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
carboplatinDrug
Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxelDrug
Also called Taxotere
Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
trastuzumabBiological
Also called Herceptin
Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (neoadjuvant therapy) | Experimental | see intervention description Receives: Drug: carboplatin; Drug: docetaxel; Biological: trastuzumab |
| Arm II (neoadjuvant therapy) | Experimental | please see intervention description Receives: Biological: trastuzumab; Drug: carboplatin; Drug: docetaxel |
| HER2/neu negative patients | Experimental | please see intervention description Receives: Drug: carboplatin; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.
Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR).
Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) \& disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen.
Measured: 5 years
Secondary outcomes (4)
Clinical Tumor Response by Physical Exam and Imaging Studies
Measured: 5 years
Tumor Response Assessment
Measured by physical examination compared to breast mammography and MRI assessment
Measured: 5 years
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
Measured: 5 years
Pathologic Nodal Status
According to Primary Tumor Response Pathologic lymph node status N0 Axillary and other nearby lymph nodes do not have cancer (when looked at under a microscope) N1 Micrometastases (very small clusters of cancer) OR 1-3 axillary lymph nodes have cancer AND/OR Internal mammary nodes have tiny amounts of cancer found on sentinel node biopsy N2 4-9 axillary lymph nodes have cancer OR Internal mammary nodes have cancer, but axillary lymph nodes do not have cancer N3 10 or more axillary lymph nodes have cancer OR Infraclavicular (under the clavicle) nodes have cancer OR Internal mammary nodes have cancer plus 1 or more axillary lymph nodes have cancer OR 4 or more axillary lymph nodes have cancer plus internal mammary nodes have cancer or micrometastases found on sentinel node biopsy OR Supraclavicular (above the clavicle) nodes have cancer
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startJul 2003
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Helena R. Chang, MD, PhD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068341
- Sponsor's protocol ID
- 99-11-084
- Other IDs
- CDR0000321924, AVENTIS-GIA-11156, GENENTECH-H2269s
- Status last verified
- Mar 2016
- First submitted
- 10 Sep 2003
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00068341
- Acronym / sponsor ID
- 99-11-084
- Conditions
- Breast Cancer
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage II breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Genentech, Inc.
- Study start
- Jul 2003
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Sep 2003 (estimated)
- Results
- Posted 27 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (neoadjuvant therapy) | Experimental | Drug: carboplatin, Drug: docetaxel, Biological: trastuzumabsee intervention description |
| Arm II (neoadjuvant therapy) | Experimental | Biological: trastuzumab, Drug: carboplatin, Drug: docetaxelplease see intervention description |
| HER2/neu negative patients | Experimental | Drug: carboplatin, Drug: docetaxelplease see intervention description |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Confirmed infiltrating adenocarcinoma of the breast
- Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.
- No prior radiation to the involved breast
- ECOG (Electrocochleography) performance status 0-2
- Age 18 years to 80 years
Key exclusion criteria (12 listed)
- Non-confirmed infiltrating adenocarcinoma breast cancer
- Evidence of metastasis
- Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin
- Prior radiation to the involved breast
- Recent breast cancer drug therapy within last 5 years of any form
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 |
|---|---|---|
| trastuzumabAlso: HerceptinCycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV | Biological | Arm II (neoadjuvant therapy) |
| carboplatinCycle 1-8 Day 1 or 2 AUC = 6 IV | Drug | Arm I (neoadjuvant therapy), Arm II (neoadjuvant therapy), HER2/neu negative patients |
| docetaxelAlso: TaxotereCycle 1-8 Day 1 or 2: 75 mg/m2 IV | Drug | Arm I (neoadjuvant therapy), Arm II (neoadjuvant therapy), HER2/neu negative patients |
| trastuzumabAlso: HerceptinCycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV | Biological | Arm I (neoadjuvant therapy) |
Primary outcome
Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.
Time frame: 5 years
Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR). Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) \& disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen.
4 secondary outcomes
Clinical Tumor Response by Physical Exam and Imaging Studies
Time frame: 5 years
Tumor Response Assessment
Time frame: 5 years
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
Time frame: 5 years
Pathologic Nodal Status
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Helena R. Chang, MD, PhD principal investigator
Jonsson Comprehensive Cancer Center
4 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 trastuzumab, carboplatin and docetaxel in people with Breast Cancer, run by Jonsson Comprehensive Cancer Center at 4 sites in United States.
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 13 inclusion and 12 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively. (time frame: 5 years). 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 9 Sep 2020.