A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
PRIMARY OBJECTIVES:
To evaluate whether the addition of chest wall + regional nodal radiation therapy (XRT)
after mastectomy or breast + regional nodal XRT after breast conserving surgery will
significantly reduce the rate of events for invasive breast cancer recurrence-free interval
(IBC-RFI) in patients who present with histologically positive axillary nodes but convert to
histologically negative axillary nodes following neoadjuvant chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate whether the addition of chest wall + regional nodal XRT after mastectomy or
breast + regional nodal XRT after breast conserving surgery will significantly prolong
overall survival (OS) in patients who present with histologically positive axillary nodes
but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.
II. To evaluate whether the addition of chest wall + regional nodal XRT after mastectomy or
breast + regional nodal XRT after breast conserving surgery will significantly reduce the
rates of events for local-regional recurrence-free interval (LRRFI) in patients who present
with histologically positive axillary nodes but convert to histologically negative axillary
nodes following neoadjuvant chemotherapy.
III. To evaluate whether the addition of chest wall + regional nodal XRT after mastectomy or
breast + regional nodal XRT after breast conserving surgery will significantly reduce the
rate of events for distant recurrence-free interval (DRFI) in patients who present with
histologically positive axillary nodes but convert to histologically negative axillary nodes
following neoadjuvant chemotherapy.
IV. To compare the rates of disease-free survival (DFS)-ductal carcinoma in situ (DCIS) by
treatment arm.
V. To compare the rates of second primary cancer (SPC) by treatment arm.
VI. To compare the effect of adding XRT on the cosmetic outcomes in mastectomy patients who
have had reconstruction.
VII. To compare the effect of adding XRT on quality of life including arm problems,
lymphedema, pain, and fatigue.
VIII. To evaluate the toxicity associated with each of the radiation therapy regimens.
IX. To determine whether computed tomography (CT)-based conformal methods
(intensity-modulated radiation therapy [IMRT] and 3-dimensional conformal radiation therapy
[3DCRT]) for chestwall + regional nodal XRT post mastectomy and regional nodal XRT with
breast XRT following breast conserving surgery are feasible in a multi-institutional setting
and whether dose-volume analyses can be established to assess treatment adequacy and to
develop normal tissue complication probabilities (NTCP) for the likelihood of toxicity.
X. To compare the effect of XRT in patients receiving mastectomy and in patients receiving
lumpectomy.
XI. To examine the role of proliferation measures as a prognosticator for patients with
residual disease after neoadjuvant chemotherapy.
XII. To develop predictors of the degree of reduction in local regional recurrence (LRR).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM 1: Patients are assigned to 1 of 2 treatment groups.
GROUP 1A: Lumpectomy patients undergo whole breast radiation therapy using IMRT or 3DCRT
once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy
cavity once daily 5 days a week for 1-1/2 weeks.
GROUP 1B: Mastectomy patients do not undergo radiation therapy.
ARM 2: Patients are assigned to 1 of 2 treatment groups.
GROUP 2A: Lumpectomy patients undergo regional nodal radiation therapy with whole breast
radiation therapy using IMRT or 3DCRT once daily 5 days a week for 5 weeks followed by a
radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.
GROUP 2B: Mastectomy patients undergo regional nodal radiation therapy and chestwall XRT
using IMRT or 3DCRT once daily 5 days a week for 5 weeks.
All patients also receive systemic therapy as planned (hormonal therapy for patients with
hormone-receptor positive breast cancer and trastuzumab or other anti-human epidermal growth
factor receptor 2 [HER2] therapy for patients with breast cancer that is HER2-positive).
After completion of study treatment, patients are followed up at 6, 12, 18, and 24 months
and then yearly for 8 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
IBC-RFI
Time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer, assessed up to 10 years
No
Norman Wolmark, MD
Principal Investigator
NSABP Foundation, Inc.
United States: Federal Government
NSABP-B-51/RTOG-1304
NCT01872975
June 2013
August 2028
Name | Location |
---|---|
National Surgical Adjuvant Breast and Bowel Project | Pittsburgh, Pennsylvania 15212-5234 |