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

Breast Cancer Clinical Trial

Official title:

A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542451
• Other study ID #: 07-199
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Est. completion date: August 30, 2022

Study information

• Verified date: November 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

• Participants will enroll in this study at the time they are starting their adjuvant therapy for breast cancer. Participants will receive chemotherapy with paclitaxel every week for 12 weeks. They will begin to receive trastuzumab at the same time they begin paclitaxel. Once they have completed the 12 weeks of paclitaxel and trastuzumab, they will receive trastuzumab every 3 weeks or weekly for 40 weeks.

• Participants will be followed with routine assessments such as physical exam and vital signs every 3 months for the first year, and then every 6 months for years 2-5. Then we would like to keep track of the participants medical condition by calling them on the telephone once per year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: August 30, 2022
• Est. primary completion date: April 21, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 18 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

• Patients with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy

• Patients undergoing breast conservation therapy must not have any contraindications to radiation therapy

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma of the Breast

Intervention

Drug:
• Paclitaxel
Every week for 12 weeks
• Trastuzumab
Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks

Locations

Country	Name	City	State
United States	John Hopkins University	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber at Faulkner Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Vermont Cancer Center	Burlington	Vermont
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Case Western University	Cleveland	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Cape Cod Healthcare	Hyannis	Massachusetts
United States	Indiana University	Indianapolis	Indiana
United States	North Shore LIJ Health System Monter Cancer Center	Lake Success	New York
United States	Lowell General Hospital	Lowell	Massachusetts
United States	Loyola University Medical Center	Maywood	Illinois
United States	Tennessee Oncology	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	North Shore Medical Center	Peabody	Massachusetts
United States	Washington University	Saint Louis	Missouri
United States	University of California-San Francisco	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease Free Survival (DFS) in Patients With Tumors Measuring =1 cm or > 1 cm	DFS is defined as the time from registration to 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. Patients without an event are censored at the date of last evaluation.	at 3 years
Secondary	Number of Patients With Grade III/IV Cardiac Left Ventricular Dysfunction	cardiac left ventricular dysfunction related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.	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).
Secondary	Number of Patients With Grade III/IV Neurotoxicity	Nervous system disorders related adverse events (AE) with any attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted.	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).
Secondary	Number of Patients With Amenorrhea	Patients that eligible for amenorrhea assessment and data collecting will be evaluated by standard method defined per protocol 3.9, through menses assessment survey.	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.