Breast CancerPhase 2NCT00769470
Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery
A Phase 2 study testing trastuzumab, carboplatin and docetaxel in people with Breast Cancer, run by Translational Oncology Research International at 15 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. 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?
- trastuzumab, carboplatin and docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 15 sitesUnited States
- Study dates
- Apr 2009to Nov 2013
- 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
- Women aged 18 to 70 years, inclusive
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Stage I, II or III disease (early stage) with tumor measuring ≥ 1 cm and meeting any the following criteria:
- Grade > 1
- Estrogen receptor- and progesterone receptor-negative
- Age ≤ 35 years
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- HER2/neu-positivity by fluorescence in situ hybridization (FISH)
- Estrogen and progesterone receptor status known prior to study entry.
- ECOG performance status 0-1 Adequate organ function (ejection fraction>- lower limit of normal) as determined by MUGA or echocardiogram.
- If female of childbearing potential, pregnancy test is negative and is willing to use effective contraception while on treatment and for at least 3 months after the last dose of study therapy.
- patient is accessible and willing to comply with treatment, tissue acquisition and follow up.
- patient is willing to provide written informed consent prior to performance of any study-related procedure.
- Adequate organ function as defined by the following laboratory values
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Creatinine < 1.5 mg/dL
- Total bilirubin ≤ 1.0 times upper limit of normal (ULN) (< 3 times ULN in patients with Gilbert's syndrome confirmed by genotyping or Invader UGTIA1 molecular assay)
- Alkaline phosphatase (AP), ALT, and AST must meet 1 of the following criteria:
- AP normal AND AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND ALT/AST ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST/ALT normal
Who cannot join
- Inflammatory breast cancer, defined as the presence of erythema or induration involving > 1/3 of the breast
- Bilateral invasive breast cancer
- Metastatic disease
- Concurrent therapy with any other non-protocol anti-cancer therapy
- history of any other malignancy within the past 5 years, with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix
- pre-existing motor or sensory neurotoxicity ≥ grade 2 by NCI NTCAE version 3.0
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- cardiac disease including any of the following:
- Myocardial infarction within the past 6 months
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- inflammatory bowel disease or other bowel condition causing chronic diarrhea and requiring active therapy
- active, uncontrolled infection requiring parenteral antimicrobials
- known hypersensitivity to Chinese hamster ovary products or other recombinant human or humanized antibodies and/or known hypersensitivity to any of the study drugs or their ingredients (e.g., polysorbate 80 in docetaxel)
- other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of study drugs or place the subject at undue risk for treatment complications
- hormonal agent (e.g., raloxifene, tamoxifen citrate, or other selective estrogen receptor modulators) for osteoporosis or prevention of breast cancer. subjects must have discontinued these agents 14 days prior to first baseline biopsy.
- prior ipsilateral radiotherapy for invasive or noninvasive breast cancer or to the ipsilateral chest wall for any malignancy
- prior chemotherapy, radiotherapy, or endocrine therapy for currently diagnosed invasive or noninvasive breast cancer
- concurrent ovarian hormonal replacement therapy. Prior treatment must be stopped prior to first baseline biopsy.
- male subjects
- pregnant or lactating subjects
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
New Mexico Cancer Center
Albuquerque, New Mexico, 87109
Central Hematology Oncology Medical Group, Incorporated - Alhambra
Alhambra, California, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309-0633
St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Providence Medical Group
Haute Terre, Indiana, 47802
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
North Valley Hematology-Oncology Medical Group
Northridge, California, 91328
Cancer Institute of Florida, PA - Orlando
Orlando, Florida, 32804
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Hematology and Oncology Consultants, PA - Orlando
Orlando, Florida, 32804
Wilshire Oncology Medical Group, Incorporated - Pomona
Pomona, California, 91767-3021
Sansum Medical Clinic
Santa Barbara, California, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
Santa Barbara Hematology Oncology - Solvang
Solvang, California, 93463
Cancer Care Associates Medical Group, Incorporated - Redondo Beach
Torrance, California, 90505
About this study
Official title: A Multicenter, Open Label, Randomized Phase II Trial of Presurgical Treatment With Single-Agent Trastuzumab (H) or Lapatinib (Ty) or the Combination of Trastuzumab and Lapatinib (H+Ty), Followed by Six Cycles of Docetaxel (T) and Carboplatin (C) With Trastuzumab (TCH) or Lapatinib (TCTy) or the Combination of Trastuzumab and Lapatinib (TCHTy) in Patients With HER2/Neu-Amplified Operable Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether docetaxel and carboplatin are more effective when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer.
PURPOSE: This randomized phase II trial is studying how well docetaxel and carboplatin work when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- To investigate the clinical efficacy of neoadjuvant docetaxel and carboplatin in combination with trastuzumab (Herceptin®) and/or lapatinib ditosylate by estimating the pathologic complete response (pCR) rate in the breast and axilla of women with HER2/neu-positive resectable stage I-III adenocarcinoma of the breast.
Secondary
- To estimate the molecular effects of lapatinib ditosylate and trastuzumab alone or in combination on tumor tissues of these patients by assessing changes in gene expression using serial gene microarray analysis.
- To assess for gene expression and/or biomarker changes that may be correlated with or predict pCR and clinical response to lapatinib ditosylate and/or trastuzumab in these patients.
- To evaluate the safety and tolerability of these regimens in these patients.
- To evaluate the clinical efficacy of these regimens by estimating the clinical objective response rate (complete response and partial response) in these patients.
- To estimate the rate of congestive heart failure or drop in LVEF (> 10% points from baseline and below lower limits of normal) in each of the three treatment arms.
OUTLINE: This is a multicenter study. Patients are stratified according to baseline tumor size (≤ 3 cm vs > 3 cm) and hormone receptor status (estrogen receptor [ER]- and/or progesterone receptor [PR]-positive vs ER- and PR- negative). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive a trastuzumab IV over 90 minutes on day 1 in course 1. Patients receive docetaxel IV, carboplatin IV, and trastuzumab IV over 30 minutes on day 1 in courses 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral lapatinib ditosylate once daily on days 1-21 in course 1. Patients receive docetaxel IV, carboplatin IV as in arm I and oral lapatinib ditosylate once daily on days 1-21 in courses 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive trastuzumab IV as in arm I on day 1 and oral lapatinib ditosylate as in arm II on days 1-21 in course 1. Patients receive docetaxel IV, carboplatin IV, and trastuzumab IV as in arm I on day 1 and oral lapatinib ditosylate as in arm II on days 1-21 in courses 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Within 4-6 weeks after completion of chemotherapy, all patients under go definitive surgery and/or radiotherapy at the discretion of the treating physician. Tumor biopsy and blood samples are collected for biomarker analysis and molecular analysis at baseline, after course 1, and at the time of definitive breast surgery or completion of chemotherapy. Gene expression changes are analyzed by mRNA microarray analysis and molecular changes in protein expression profiles by IHC. Samples may also be analyzed by RT-PCR.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, carboplatin, docetaxel, lapatinib ditosylate
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, HER2-positive 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
Given IV
carboplatinDrug
Given IV
docetaxelDrug
Given IV
lapatinib ditosylateDrug
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive trastuzumab IV over 90 minutes on day in course 1. Patients receive docetaxel IV, carboplatin IV, and trastuzumab IV over 30 minutes on day 1 in course 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: trastuzumab; Drug: carboplatin; Drug: docetaxel |
| Arm II | Experimental | Patients receive oral lapatinib ditosylate once daily on days 1-21 in course 1. Patients receive docetaxel IV and carboplatin IV on day 1 and oral lapatinib ditosylate once daily on days 1-21 in courses 2-7.Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: carboplatin; Drug: docetaxel; Drug: lapatinib ditosylate |
| Arm III | Experimental | Patients receive trastuzumab IV over 90 minutes on day 1 and oral lapatinib ditosylate daily on days 1-21. Starting on day 22, patients receive docetaxel IV, carboplatin IV, and trastuzumab IV three times a week and oral lapatinib ditosylate once daily on days 1-21 in courses 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: trastuzumab; Drug: carboplatin; Drug: docetaxel; Drug: lapatinib ditosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
Measured: 7 months
Secondary outcomes (1)
Comparison of pCR rates
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startApr 2009
- Primary completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Oncology Research International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Hurvitz, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769470
- Sponsor's protocol ID
- CDR0000616008
- Other IDs
- P30CA016042, TRIO-TORI-B-07, SANOFI-AVENTIS-TRIO-TORI-B-07, WIRB-20080822
- Status last verified
- Jan 2016
- First submitted
- 8 Oct 2008
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hurvitz SA, Caswell-Jin JL, McNamara KL, Zoeller JJ, Bean GR, Dichmann R, Perez A, Patel R, Zehngebot L, Allen H, Bosserman L, DiCarlo B, Kennedy A, Giuliano A, Calfa C, Molthrop D, Mani A, Chen HW, Dering J, Adams B, Kotler E, Press MF, Brugge JS, Curtis C, Slamon DJ. Pathologic and molecular responses to neoadjuvant trastuzumab and/or lapatinib from a phase II randomized trial in HER2-positive breast cancer (TRIO-US B07). Nat Commun. 2020 Nov 17;11(1):5824. doi: 10.1038/s41467-020-19494-2.
PubMed 33203854
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Randomized Phase II Trial of Presurgical Treatment With Single-Agent Trastuzumab (H) or Lapatinib (Ty) or the Combination of Trastuzumab and Lapatinib (H+Ty), Followed by Six Cycles of Docetaxel (T) and Carboplatin (C) With Trastuzumab (TCH) or Lapatinib (TCTy) or the Combination of Trastuzumab and Lapatinib (TCHTy) in Patients With HER2/Neu-Amplified Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00769470
- Acronym / sponsor ID
- CDR0000616008
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, HER2-positive breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Translational Oncology Research InternationalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, Los Angeles
- Study start
- Apr 2009
- Primary completion
- Nov 2013 (actual)
- First posted
- 9 Oct 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.
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether docetaxel and carboplatin are more effective when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer.
PURPOSE: This randomized phase II trial is studying how well docetaxel and carboplatin work when given together with trastuzumab and/or lapatinib in treating women with stage I, stage II, or stage III breast cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- To investigate the clinical efficacy of neoadjuvant docetaxel and carboplatin in combination with trastuzumab (Herceptin®) and/or lapatinib ditosylate by estimating the pathologic complete response (pCR) rate in the breast and axilla of women with HER2/neu-positive resectable stage I-III adenocarcinoma of the breast.
Secondary
- To estimate the molecular effects of lapatinib ditosylate and trastuzumab alone or in combination on tumor tissues of these patients by assessing changes in gene expression using serial gene microarray analysis.
- To assess for gene expression and/or biomarker changes that may be correlated with or predict pCR and clinical response to lapatinib ditosylate and/or trastuzumab in these patients.
- To evaluate the safety and tolerability of these regimens in these patients.
- To evaluate the clinical efficacy of these regimens by estimating the clinical objective response rate (complete response and partial response) in these patients.
- To estimate the rate of congestive heart failure or drop in LVEF (> 10% points from baseline and below lower limits of normal) in each of the three treatment arms.
OUTLINE: This is a multicenter study. Patients are stratified according to baseline tumor size (≤ 3 cm vs > 3 cm) and hormone receptor status (estrogen receptor [ER]- and/or progesterone receptor [PR]-positive vs ER- and PR- negative). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive a trastuzumab IV over 90 minutes on day 1 in course 1. Patients receive docetaxel IV, carboplatin IV, and trastuzumab IV over 30 minutes on day 1 in courses 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral lapatinib ditosylate once daily on days 1-21 in course 1. Patients receive docetaxel IV, carboplatin IV as in arm I and oral lapatinib ditosylate once daily on days 1-21 in courses 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive trastuzumab IV as in arm I on day 1 and oral lapatinib ditosylate as in arm II on days 1-21 in course 1. Patients receive docetaxel IV, carboplatin IV, and trastuzumab IV as in arm I on day 1 and oral lapatinib ditosylate as in arm II on days 1-21 in courses 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Within 4-6 weeks after completion of chemotherapy, all patients under go definitive surgery and/or radiotherapy at the discretion of the treating physician. Tumor biopsy and blood samples are collected for biomarker analysis and molecular analysis at baseline, after course 1, and at the time of definitive breast surgery or completion of chemotherapy. Gene expression changes are analyzed by mRNA microarray analysis and molecular changes in protein expression profiles by IHC. Samples may also be analyzed by RT-PCR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Biological: trastuzumab, Drug: carboplatin, Drug: docetaxelPatients receive trastuzumab IV over 90 minutes on day in course 1. Patients receive docetaxel IV, carboplatin IV, and trastuzumab IV over 30 minutes on day 1 in course 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Drug: carboplatin, Drug: docetaxel, Drug: lapatinib ditosylatePatients receive oral lapatinib ditosylate once daily on days 1-21 in course 1. Patients receive docetaxel IV and carboplatin IV on day 1 and oral lapatinib ditosylate once daily on days 1-21 in courses 2-7.Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Arm III | Experimental | Biological: trastuzumab, Drug: carboplatin, Drug: docetaxel, Drug: lapatinib ditosylatePatients receive trastuzumab IV over 90 minutes on day 1 and oral lapatinib ditosylate daily on days 1-21. Starting on day 22, patients receive docetaxel IV, carboplatin IV, and trastuzumab IV three times a week and oral lapatinib ditosylate once daily on days 1-21 in courses 2-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Women aged 18 to 70 years, inclusive
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Stage I, II or III disease (early stage) with tumor measuring ≥ 1 cm and meeting any the following criteria:
- HER2/neu-positivity by fluorescence in situ hybridization (FISH)
- Estrogen and progesterone receptor status known prior to study entry.
Key exclusion criteria (20 listed)
- Inflammatory breast cancer, defined as the presence of erythema or induration involving > 1/3 of the breast
- Bilateral invasive breast cancer
- Metastatic disease
- Concurrent therapy with any other non-protocol anti-cancer therapy
- history of any other malignancy within the past 5 years, with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix
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 |
|---|---|---|
| trastuzumabGiven IV | Biological | Arm I, Arm III |
| carboplatinGiven IV | Drug | Arm I, Arm II, Arm III |
| docetaxelGiven IV | Drug | Arm I, Arm II, Arm III |
| lapatinib ditosylateGiven orally | Drug | Arm II, Arm III |
Primary outcome
Pathologic complete response (pCR)
Time frame: 7 months
1 secondary outcome
Comparison of pCR rates
Time frame: 7 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 22 Jan 2016.
- Derived from this study: PubMed 33203854Hurvitz SA, Caswell-Jin JL, McNamara KL, Zoeller JJ, Bean GR, Dichmann R, Perez A, Patel R, Zehngebot L, Allen H, Bosserman L, DiCarlo B, Kennedy A, Giuliano A, Calfa C, Molthrop D, Mani A, Chen HW, Dering J, Adams B, Kotler E, Press MF, Brugge JS, Curtis C, Slamon DJ. Pathologic and molecular responses to neoadjuvant trastuzumab and/or lapatinib from a phase II randomized trial in HER2-positive breast cancer (TRIO-US B07). Nat Commun. 2020 Nov 17;11(1):5824. doi: 10.1038/s41467-020-19494-2.
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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.
Sara Hurvitz, MD principal investigator
Jonsson Comprehensive Cancer Center
15 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 Translational Oncology Research International at 15 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 22 inclusion and 20 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 22 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 15 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?
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?
Pathologic complete response (pCR) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769470, which also lists 1 linked publication.
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 22 Jan 2016.