|Title||NSABP 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|
NSABP B-43 -mA 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
The purpose of this study is to determine the value of trastuzumab given during radiation therapy (RT) compared to RT alone in preventing the subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral DCIS (IIBCR-SCR-DCIS) in women with HER2-positive DCIS resected by lumpectomy.
|Inclusion/Notes||Although the guidelines in Section 4.1 are not inclusion/exclusion criteria, investigators should consider each of these factors when selecting patients for B-43. Investigators should also consider all other relevant factors (medical and non-medical), as well as the risks and benefits of the study therapy when deciding whether a patient is appropriate for B-43. These considerations should be weighed carefully, as they may make a patient an unsuitable candidate for B-43 and may increase risk to the patient.
Pre-entry central HER2 testing (see Sections 6.1 and 6.2 and Appendix C) is required for all patients. The correlative studies are required for all patients enrolled in B-43 (see Appendix D). Therefore, submission of a tumor block for the B-43 trial is required. The local pathology department policy regarding release of blocks must be considered when screening patients.
Patients with a life expectancy of less than 10 years, excluding the diagnosis of ductal carcinoma in situ of the breast. (Comorbid conditions should be taken into consideration, but not the DCIS diagnosis.)
Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after completion of trastuzumab.
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Patients who meet the following criteria may participate in this study:
The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the study treatment and for the pre-entry tumor block submission for HER2 testing and B-43 correlative studies
Patients must be female.
Patients must be 18 years of age or older.
Patients must have an ECOG performance status of 0 or 1 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory).
On histologic examination, the tumor must be ductal carcinoma in situ (DCIS).
(Patients with mixed DCIS and lobular carcinoma in situ [LCIS] are eligible.)
The DCIS must be HER2-positive as determined by central testing
Estrogen and/or progesterone receptor status must be determined prior to randomization. (Patients with DCIS that is hormone receptor positive or negative are eligible.)
All DCIS must have been resected by lumpectomy.
The margins of the resected specimen must be histologically free of DCIS. For patients in whom pathologic examination demonstrates DCIS present at the line of resection, re-excision(s) may be performed to obtain clear margins. (Patients who require mastectomy are not eligible.)
If axillary staging is performed, nodal staging must be pN0, pN0(i–), pN0(i+) which is defined as isolated tumor cells = 0.2 mm, regardless of the method of detection, i.e., IHC or H&E, pN0(mol–), or pN0(mol+). Note: Axillary staging is not required. (Refer to AJCC Staging Criteria in the Treatment Trial Information section in the Members' Area of the NSABP Web site for TNM nomenclature and staging information.)
The interval between the last surgery for excision of DCIS (lumpectomy or reexcision of lumpectomy margins) and randomization must be no more than 120 days.
Invasive (including microinvasion staged as T1mic) breast cancer. (Patients with DCIS “suspicious” for microinvasion, but not confirmed, are eligible.)
Nodal staging of pN1 (including pN1mi). (Note: Axillary staging is not required.)
DCIS present in more than one quadrant (multicentric).
Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign. (If DCIS is found, the patient is eligible if the DCIS was in the same quadrant of the ipsilateral breast and was resected with clear margins.)
Contralateral breast cancer (including DCIS).
Whole breast irradiation administered before randomization. (Partial breast irradiation is prohibited.)
Prior history of breast cancer, including DCIS. (Patients with a history of LCIS are eligible.)
Prior anthracycline chemotherapy for any malignancy.