B-43 - A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy 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-43 - A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy
Description	This study is being done to find out if adding a drug called trastuzumab to breast radiation therapy, will be more effective than radiation therapy without trastuzumab in treating DCIS(ductal carcinoma in situ). DCIS means that the cancer cells are only in the milk ducts in the breast and have not spread to other breast tissue or to other parts of the body. Radiation therapy is the standard treatment for patients with DCIS. Trastuzumab is considered to be investigationsl (still being researched) because it has not been approved by the U.S.Food and Drug Administration for use in the treatment of DCIS. Summary of Study Therapy. The patient will be randomized to one of the following study groups: Group 1 - Breast radiation therapy Group 2 - Breast radiation therapy + Trastuzumab (D0se 1) given through a vein over 90 minutes Followed 3 weeks later by Trastuzumab (Dose 2) given through a veing over 30 minutes (if Dose 1 is well tolerated)
Treatment	Oncology
Inclusion/Notes	Eligibility: - must consent to participate - Must be a female - Must be 18 years of age or older - ECOG performance status of 0 or 1 - histological examination,tumor must be ductal carcinoma in situe (DCIS) - the DCIS must be HER2-positive as determined by central testing - estrogen and/or progesterone receptor status must be determined prior to randomization - All DCIS must have been resected by lumpectomy - margins must be histologically free of DCIS Ineligiblity: -Invasive breast cancer -Nodal involment -DCIS preset in more than one quadrant -whole breast irradiation administered before randomization -prior history of breast cancer, including DCIS -prior chemotherapy -cardiac disease that would preclude the use of the drugs -pregnancy or lactation at the time of study entry
Status	Accruing
Start Date	11/10/2008
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-43 - A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy

Description

This study is being done to find out if adding a drug called trastuzumab to breast radiation therapy, will be more effective than radiation therapy without trastuzumab in treating DCIS(ductal carcinoma in situ). DCIS means that the cancer cells are only in the milk ducts in the breast and have not spread to other breast tissue or to other parts of the body.

Radiation therapy is the standard treatment for patients with DCIS. Trastuzumab is considered to be investigationsl (still being researched) because it has not been approved by the U.S.Food and Drug Administration for use in the treatment of DCIS.

Summary of Study Therapy. The patient will be randomized to one of the following study groups:
Group 1 - Breast radiation therapy
Group 2 - Breast radiation therapy
+
Trastuzumab (D0se 1) given through a vein over 90 minutes
Followed 3 weeks later by
Trastuzumab (Dose 2) given through a veing over 30 minutes (if Dose 1 is well tolerated)

Treatment

Oncology

Inclusion/Notes

Eligibility:
- must consent to participate
- Must be a female
- Must be 18 years of age or older
- ECOG performance status of 0 or 1
- histological examination,tumor must be ductal carcinoma in situe (DCIS)
- the DCIS must be HER2-positive as determined by central testing
- estrogen and/or progesterone receptor status must be determined prior to randomization
- All DCIS must have been resected by lumpectomy
- margins must be histologically free of DCIS

Ineligiblity:
-Invasive breast cancer
-Nodal involment
-DCIS preset in more than one quadrant
-whole breast irradiation administered before randomization
-prior history of breast cancer, including DCIS
-prior chemotherapy
-cardiac disease that would preclude the use of the drugs
-pregnancy or lactation at the time of study entry

Status

Accruing

Start Date

11/10/2008

Current Trial Type

Treatment

Clinical Trials