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Breast CancerPhase 2NCT00820872

Docetaxel, Carboplatin, Trastuzumab, and Lapatinib in Treating Patients With Early Stage Breast Cancer

A Phase 2 study testing trastuzumab, carboplatin and docetaxel in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 136 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 years and older
Conditions the study is for
Breast Cancer
What is being tested?
trastuzumab, carboplatin and docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
136 sitesUnited States
Study dates
Feb 2009to 15 Aug 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary invasive adenocarcinoma of the breast fulfilling the following criteria:
  • Nonmetastatic disease
  • Operable and adequately excised
  • Patients with nonresectable deep margin invasion are eligible provided they have had or will receive radiotherapy to the region
  • Patients with histologically documented infiltration of the skin (pT4) are eligible provided they have undergone or will receive radiotherapy encompassing the tumor bed
  • Node-positive OR -negative and determined eligible to receive adjuvant trastuzumab (Herceptin®)
  • No positive or suspicious internal mammary nodes by SNS that have not been or will not be irradiated
  • No supraclavicular lymph node involvement (confirmed by fine needle aspiration or biopsy)
  • Over expression and/or amplification of HER2 in the invasive component of the primary tumor, according to one of the following:
  • 3+ over-expression by IHC (> 30% of invasive tumor cells)
  • 2+ or 3+ (in 30% or less neoplastic cells) over-expression by IHC AND in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification
  • HER2 gene amplification by FISH/CISH (> 6 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of > 2.2.)
  • Negative or equivocal overall result (FISH test ratio of < 2.2, < 6.0 HER2-gene copies per nucleus) and staining scores of 0, 1+, 2+, or 3+ (in 30% or less neoplastic cells) by IHC not allowed
  • Hormone receptor status known (estrogen receptor with or without progesterone receptor)

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-1
  • Hemoglobin ≥ 10.0 g/dL
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if known Gilbert syndrome)
  • Baseline LVEF ≥ 50% measured by ECHO or MUGA scan
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious cardiac illness or medical condition including, but not limited to, any of the following:
  • History of documented congestive heart failure (any NYHA class) or systolic dysfunction (LVEF < 50%)
  • High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade atrioventricular-block [second degree or higher], or supraventricular arrhythmias that are not adequately rate-controlled)
  • Angina pectoris requiring antianginal medication
  • Clinically significant valvular heart disease
  • Evidence of transmural infarction on ECG
  • Poorly controlled hypertension (any reading of systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg)
  • No other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions or illness
  • None of the following:
  • Ulcerative colitis
  • Malabsorption syndrome
  • Any disease significantly affecting gastrointestinal function
  • Inability to swallow oral medication

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior mediastinal irradiation except internal mammary-node irradiation for the present breast cancer
  • No prior anti-HER2 therapy for any reason
  • No prior biologic or immunotherapy for breast cancer
  • No prior resection of the stomach or small bowel
  • No other concurrent anticancer therapy including chemotherapeutic agents, biologic agents, or radiotherapy
  • No concurrent anticancer treatment in another investigational trial with hormone therapy or immunotherapy unless approved by the study chair
  • No concurrent CYP3A4 inhibitors or inducers
  • No concurrent epoetin alfa, including darbepoetin alfa
  • No concurrent oprelvekin

Trial locations and contacts

136 sites in 1 country.

136 sites in 1 country

United States136 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Study site

    Bettendorf, Iowa, 52722

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Wood County Oncology Center

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • North Coast Cancer Care - Clyde

    Clyde, Ohio, 43410

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Northern Montana Hospital

    Havre, Montana, 59501

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan, 48144

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota, 55109

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • St. Luke's Hospital

    Maumee, Ohio, 43537

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

    Moline, Illinois, 61265

  • Study site

    Moline, Illinois, 61265

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic - Oregon

    Oregon, Ohio, 43616

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • South Bend Clinic

    South Bend, Indiana, 46617

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: Phase II Safety Study of Docetaxel and Carboplatin in Combination With Trastuzumab and Lapatinib in Early 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. Giving docetaxel together with carboplatin, trastuzumab, and lapatinib may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with carboplatin, trastuzumab, and lapatinib in treating patients with early stage breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety and tolerability (including the rate of diarrhea) of adjuvant therapy comprising docetaxel, carboplatin, trastuzumab (Herceptin®), and lapatinib ditosylate in patients with early-stage breast cancer.

Secondary

  • Evaluate the adverse event profile of this regimen in these patients.
  • Evaluate LVEF in patients receiving this regimen.

OUTLINE: Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity..

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.

Conditions
Breast Cancer
Being tested
trastuzumab, carboplatin, docetaxel, lapatinib ditosylate
Keywords
male breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
Medical subject headings
Breast Neoplasms, Breast Neoplasms, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00820872
Study groupRoleWhat they receive
docetaxel + carboplatin + trastuzumab + lapatinibExperimentalPatients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
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.

  1. Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2010
  4. Study completion15 Aug 2019

Resources

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00820872
Sponsor's protocol ID
NCCTG-N083E
Other IDs
NCI-2009-00671, CDR0000631625
Status last verified
Oct 2019
First submitted
9 Jan 2009
Last updated
21 Oct 2019
Data monitoring committee
No

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 Alliance for Clinical Trials in Oncology at 136 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?

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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 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 22 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?

Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0 (time frame: Up to 10 years). 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 NCT00820872.

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 Oct 2019.

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