NCT00542451

Brief Summary

The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2014

Completed
8.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 27, 2023

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

6.6 years

First QC Date

October 9, 2007

Results QC Date

November 1, 2022

Last Update Submit

June 24, 2024

Conditions

Breast CancerCarcinoma of the Breast

Keywords

node-negative breast cancerHER-2 positive

Outcome Measures

Primary Outcomes (1)

  • 3-year Disease Free Survival (DFS) Rate

    Disease-free survival (DFS) is the proportion of participants ramaing disease free at 3 years based on the Kaplan-Meier method. DFS is defined to end at the time of the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause.

    at 3 years

Secondary Outcomes (4)

  • Disease Free Survival (DFS) in Patients With Tumors Measuring ≤1 cm or > 1 cm

    at 3 years

  • Number of Patients With Grade III/IV Cardiac Left Ventricular Dysfunction

    AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months).

  • Number of Patients With Grade III/IV Neurotoxicity

    AE evaluated on treatment every week during paclitaxel and every 9 weeks during trastuzumab monotheryapy, and at progression, and observation years 2-10. Median treatment duration was 11.4 months (range 0 - 23.5 months).

  • Number of Patients With Amenorrhea

    Menses Assessment survey on Q6 months x 1 year, then q6months for year 2 and at progression, and observation years 2-10 or until progression.

Study Arms (1)

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

EXPERIMENTAL

80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab, the dosing of Trastuzumab could be continued on a weekly basis, or the regimen could be changed to 6 mg per kilogram every 3 weeks for 40 weeks to complete a full year of intravenous treatment with trastuzumab.

Drug: PaclitaxelDrug: Trastuzumab

Interventions

PaclitaxelDRUG

Every week for 12 weeks

Also known as: Taxol
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
TrastuzumabDRUG

Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks

Also known as: Herceptin
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed invasive carcinoma of the breast
  • Tumors must be less than or equal to 3cm in greatest dimension
  • Must have node-negative breast cancer according to teh AJCC 7th edition
  • ER/PR determination is required. ER- and PR-assays should be performed by immunohistochemical methods
  • HER-2 positive: IHC 3+ or FISH \>2
  • Bilateral breast cancers that individually meet eligibility criteria are allowed
  • Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides must be sent to DFCI for testing
  • Less than or equal to 84 days from mastectomy or from axillary dissection or sentinel node biopsy if the patient's most extensive breast surgery was a breast-sparing procedure
  • All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
  • years of age or older
  • ECOG Performance Status of 0 or 1
  • Adequate bone marrow function, hepatic function, and renal function as outlined in protocol
  • Left ventricular ejection fraction of greater than or equal to 50%
  • Willingness to discontinue any hormonal agent prior to registration and while on study
  • Willingness to discontinue sex hormonal therapy, e.g. birth control pills, prior to registration and while on study
  • +2 more criteria

You may not qualify if:

  • Pregnant or nursing women
  • Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes
  • History of prior chemotherapy in past 5 years
  • History of prior trastuzumab therapy
  • Active, unresolved infection
  • Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent
  • Sensitivity to benzyl alcohol
  • Grade 2 or greater neuropathy per NCI's CTCAv3.0. (Exception: Any chronic neurologic disorder will be looked at on a case-by-case basis by the study chair).
  • Active cardiac disease as outlined in protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

University of California-San Francisco

San Francisco, California, 94115, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

John Hopkins University

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber at Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Cape Cod Healthcare

Hyannis, Massachusetts, 02601, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

North Shore Medical Center

Peabody, Massachusetts, 01960, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

North Shore LIJ Health System Monter Cancer Center

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Case Western University

Cleveland, Ohio, 44195, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

University of Vermont Cancer Center

Burlington, Vermont, 05401, United States

Location

Related Publications (4)

  • Tolaney SM, Tarantino P, Graham N, Tayob N, Pare L, Villacampa G, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Barroso-Sousa R, Villagrasa P, DeMeo M, DiLullo M, Zanudo JGT, Weiss J, Wagle N, Partridge AH, Waks AG, Hudis CA, Krop IE, Burstein HJ, Prat A, Winer EP. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial. Lancet Oncol. 2023 Mar;24(3):273-285. doi: 10.1016/S1470-2045(23)00051-7.

    PMID: 36858723DERIVED

  • Tolaney SM, Guo H, Pernas S, Barry WT, Dillon DA, Ritterhouse L, Schneider BP, Shen F, Fuhrman K, Baltay M, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer B, Partridge AH, Hudis CA, Krop IE, Burstein HJ, Winer EP. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. J Clin Oncol. 2019 Aug 1;37(22):1868-1875. doi: 10.1200/JCO.19.00066. Epub 2019 Apr 2.

    PMID: 30939096DERIVED

  • Barroso-Sousa R, Barry WT, Guo H, Dillon D, Tan YB, Fuhrman K, Osmani W, Getz A, Baltay M, Dang C, Yardley D, Moy B, Marcom PK, Mittendorf EA, Krop IE, Winer EP, Tolaney SM. The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial. Ann Oncol. 2019 Apr 1;30(4):575-581. doi: 10.1093/annonc/mdz047.

    PMID: 30753274DERIVED

  • Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med. 2015 Jan 8;372(2):134-41. doi: 10.1056/NEJMoa1406281.

    PMID: 25564897DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PaclitaxelTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
SARA TOLANEY, MD, MPH
Organization
Dana Farber Cancer Institute
Sara_Tolaney@dfci.harvard.edu
617-632-3800

Study Officials

  • Sara Tolaney, MD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2007

First Posted

October 11, 2007

Study Start

October 1, 2007

Primary Completion

April 21, 2014

Study Completion

August 30, 2022

Last Updated

June 26, 2024

Results First Posted

March 27, 2023

Record last verified: 2024-06

Locations

US(20)