A011104: Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer

Study ID
STU 082013-054

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Todd Morgan
214-648-7020
todd.morgan@utsouthwestern.edu

Principal Investigator
Ann Leitch

Summary

This is a phase iii study to see whether a preoperative breast MRi ulimately improves local regional control to women who have had BCT Breast assessment to be able to distinguish whether preoperative breast MRi improves local staging and ultimately improves local regional staging

once BCT assessed by standard criteria the women will be randomized into one of two arems . arm 1 will be current standard of care, clinical examination and mammography (+/- ultrasound) and currentstandard of care followed by breast conserving surgery (BCS).

arm 2 (experimental): Clinical breast examination, mammography with ultrasound (uS) of breast and regional nodes (if uS is a standard component of institutional preoperative assessments) and breast MRi; followed by breast conserving surgery (BCS) or mastectomy.

Patients randomized to arm i will proceed directly to breast conserving surgery (BCS).

Patients randomized to arm 2 who remain eligible for breast conserving surgery after MRi (see Section 5.2), will similarly proceed to BCS.

endpoints
The primary endpoint is local-regional recurrence in the ipsilateral breast following breast conserving surgery. Local-regional recurrence (LRR) is defined as ipsilateral DCiS or invasive breast tumor recurrence in the preserved breast or invasive cancer in the chest wall and skin recurrence following mastectomy, and/or invasive breast cancer in the axilla or regional lymph nodes.

Secondary endpoints include:
Re-operation rate following attempted breast conserving therapy wi ii be computed for each arm. For women randomized to the no pre-operative breast MRi arm, this rate will be computed as the number of women who had a re-operation (including mastectomy) divided by the total number of women randomized to this arm. For women randomized to the pre-operative breast MRi arm, this rate will be computed as the number of women for whom BCT was indicated by MRi who had a re-operation (including mastectomy) divided by the number of women for whom BCT was indicated by MRi.






Participant Eligibility

A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
I. Female. Men are excluded from this study because the number of men with breast cancer is
insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
2. Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 NO MO, T0-2 N1 MO). Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded.
3. Patients must have either:
a. ER negative/PR negative ( OR
b. ER negative/PR negative(< 1% by IHC staining) and HER-2 positve tumors.
c. HER2 status will be determined as per the 2013 ASCO CAP guidelines:
i. HER2 is considered positive if a) there is IHC 3+ staining or b) ISH positive
using either single probe ISH or dual probe ISH
ii. HER2 is considered negative if a) there is IHC 0 or 1+ staining or b) ISH
negative using either single probe ISH or dual probe ISH
*
>/= 18 years of age.

Signed study-specific informed consent prior to registration.