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

NCT00769470 | Completed Phase 2 DMC

• 5 other identifiers: CDR0000616008P30CA016042TRIO-TORI-B-07SANOFI-AVENTIS-TRIO-TORI-B-07WIRB-20080822
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 15

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR)

  7 months

Secondary Outcomes (1)

• Comparison of pCR rates

  7 months

Study Arms (3)

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.

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.

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.

Biological: trastuzumab; Drug: carboplatin; Drug: docetaxel; Drug: lapatinib ditosylate

Interventions

trastuzumab BIOLOGICAL

Given IV

Arm I; Arm III

carboplatin DRUG

Given IV

Arm I; Arm II; Arm III

docetaxel DRUG

Given IV

Arm I; Arm II; Arm III

lapatinib ditosylate DRUG

Given orally

Arm II; Arm III

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Translational Oncology Research International: lead
• National Cancer Institute (NCI): collaborator
• University of California, Los Angeles: collaborator

Study Sites (15)

Central Hematology Oncology Medical Group, Incorporated - Alhambra

Alhambra, California, 91801, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309-0633, United States

Location

St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center

Fullerton, California, 92835, United States

Location

North Valley Hematology-Oncology Medical Group

Northridge, California, 91328, United States

Location

Wilshire Oncology Medical Group, Incorporated - Pomona

Pomona, California, 91767-3021, United States

Location

Sansum Medical Clinic

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

Santa Barbara Hematology Oncology - Solvang

Solvang, California, 93463, United States

Location

Cancer Care Associates Medical Group, Incorporated - Redondo Beach

Torrance, California, 90505, United States

Location

Cancer Institute of Florida, PA - Orlando

Orlando, Florida, 32804, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Hematology and Oncology Consultants, PA - Orlando

Orlando, Florida, 32804, United States

Location

Providence Medical Group

Haute Terre, Indiana, 47802, United States

Location

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052, United States

Location

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

Location

Related Publications (1)

• 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.

  PMID: 33203854 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Carboplatin; Docetaxel; Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sara Hurvitz, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: April 1, 2009
• Primary Completion: November 1, 2013
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

US (15)