B-47 - A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High Risk N ode-Negative HER2-Low Invasive Breast Cancer Pittsfield, Massachusetts (MA)

Principal Name	Harvey Zimbler, MD
Contact Name	Gloria Gero
Phone	(413) 496-8205
Alternate Phone	(413) 443-6000
Fax	(413) 443-2203
Title	B-47 - A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High Risk N ode-Negative HER2-Low Invasive Breast Cancer
Description	The purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning. Stratification: - IHC score (1+,2+) - Number of positive nodes (0-3, 4-9, 10+) - Hormone receptor status (ER-[ositive and/or PgR-positive, ER- and PgR-negative) - Intended chemotherapy regiemn (TC [Docetaxel + cyclophosphamide], AC followed by WP [doxorubicin + cyclophosphamide follwed by weekly pactlitaxel]) Randomization: Arm 1 Arm 2 (groups 1A and 1B) (Groups 2A and 2B) Chemotherapy Chemotherapy (TC or AC followed by WP) + Trastuzumab x 1 year (TC + trastuzumab or AC followed by WP + trastuzumab)
Treatment	Oncology
Inclusion/Notes	Eligiblity: - signed consent - female - must be over 18 years old - ECOG performance status of 0 or 1 - tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination - appropriate staging criteria must be met (7th Ediction of AJCC Cancer Staging Manual) - HER2 status of primary tumor must be evaluated prior to randomiation - patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy) - patient must have completed a pathologic nodal status - ER analysis performed on primary tumor prior to randomization - appropriate blood tests meeting eligibility criteria Ineligibility: - T4 tumors including inflammatory breast cancer - definitive clinical or radiologic evidence of metastatic disease - previous history of ipsilateral invasive breast cancer or ipsilateral DCIS - history of non-breast malignancies within 5 years prior to randomization - previous chemotherapy - active hepatitis B or hepatitis C with abnormal liver function tests - poorly controlled diabets mellitus
Status	accruing
Current Trial Type	treatment

Principal Name

Harvey Zimbler, MD

Contact Name

Gloria Gero

Phone

(413) 496-8205

Alternate Phone

(413) 443-6000

Fax

(413) 443-2203

Title

B-47 - A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High Risk N ode-Negative HER2-Low Invasive Breast Cancer

Description

The purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.
Stratification:
- IHC score (1+,2+)
- Number of positive nodes (0-3, 4-9, 10+)
- Hormone receptor status (ER-[ositive and/or PgR-positive, ER- and PgR-negative)
- Intended chemotherapy regiemn (TC [Docetaxel + cyclophosphamide], AC followed by WP [doxorubicin + cyclophosphamide follwed by weekly pactlitaxel])

Randomization:
Arm 1 Arm 2
(groups 1A and 1B) (Groups 2A and 2B)
Chemotherapy Chemotherapy
(TC or AC followed by WP) +
Trastuzumab x 1 year
(TC + trastuzumab or
AC followed by WP + trastuzumab)

Treatment

Oncology

Inclusion/Notes

Eligiblity:
- signed consent
- female
- must be over 18 years old
- ECOG performance status of 0 or 1
- tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
- appropriate staging criteria must be met (7th Ediction of AJCC Cancer Staging Manual)
- HER2 status of primary tumor must be evaluated prior to randomiation
- patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy)
- patient must have completed a pathologic nodal status
- ER analysis performed on primary tumor prior to randomization
- appropriate blood tests meeting eligibility criteria

Ineligibility:
- T4 tumors including inflammatory breast cancer
- definitive clinical or radiologic evidence of metastatic disease
- previous history of ipsilateral invasive breast cancer or ipsilateral DCIS
- history of non-breast malignancies within 5 years prior to randomization
- previous chemotherapy
- active hepatitis B or hepatitis C with abnormal liver function tests
- poorly controlled diabets mellitus

Status

accruing

Current Trial Type

treatment

Clinical Trials