Trial Outcomes & Findings for Proton Therapy for Early Stage Breast Cancer (NCT NCT00614172)

NCT ID: NCT00614172

Last Updated: 2023-09-21

Results Overview

Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Up to 5 years post-treatment completion, average of 48 months
• Results posted on: 2023-09-21

Participant Flow

Participant milestones

Measure	Proton Radiotherapy Two week course of proton radiotherapy to the breast. Proton radiation therapy: Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Partial Breast Radiotherapy With Proton Beam n=50 Participants Two weeks of proton beam radiotherapy to the lumpectomy site
Age, Continuous	63 years n=50 Participants
Sex: Female, Male Female	50 Participants n=50 Participants
Sex: Female, Male Male	0 Participants n=50 Participants
Histology Ductal	40 Participants n=50 Participants
Histology Mucinous	5 Participants n=50 Participants
Histology Tubular	4 Participants n=50 Participants
Histology Medullary	1 Participants n=50 Participants
Involved Breast Right	27 Participants n=50 Participants
Involved Breast Left	23 Participants n=50 Participants
Tumor Size (cm)	1.3 CM n=50 Participants
ER Receptor Status ER+ (>10% Tumor Cells Positive)	44 Participants n=50 Participants
ER Receptor Status ER-	6 Participants n=50 Participants

PRIMARY outcome

Timeframe: Up to 5 years post-treatment completion, average of 48 months

Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam

Outcome measures

Measure	Partial Breast Radiotherapy With Proton Beam n=50 Participants Two weeks of proton beam radiotherapy to the lumpectomy site
Ipsilateral Breast Tumor Recurrence-free Survival	92 percentage of patients Interval 82.0 to 100.0

SECONDARY outcome

Timeframe: Up to 5 years post- completion of treatment, average 48 months

Overall survival rate at 5 years post-treatment completion.

Outcome measures

Measure	Partial Breast Radiotherapy With Proton Beam n=50 Participants Two weeks of proton beam radiotherapy to the lumpectomy site
Overall Survival	96 % Alive Interval 84.0 to 100.0

Adverse Events

Proton Radiotherapy

Serious events: 49 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Proton Radiotherapy n=50 participants at risk Two week course of proton radiotherapy to the breast. Proton radiation therapy: Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Distant metatastatic disease	6.0% 3/50 • Number of events 3 • Change between baseline pre-treatment and 5 years post-treatment completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Isolated axillary occurence	2.0% 1/50 • Number of events 1 • Change between baseline pre-treatment and 5 years post-treatment completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Events Leading to Death	2.0% 1/50 • Number of events 1 • Change between baseline pre-treatment and 5 years post-treatment completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esopageal Carcinoma	2.0% 1/50 • Number of events 1 • Change between baseline pre-treatment and 5 years post-treatment completion.
Skin and subcutaneous tissue disorders Grade 1 - 2 Acute Skin Toxicity	60.0% 30/50 • Number of events 30 • Change between baseline pre-treatment and 5 years post-treatment completion.
Blood and lymphatic system disorders Telangiectasia	26.0% 13/50 • Number of events 13 • Change between baseline pre-treatment and 5 years post-treatment completion.

Other adverse events

Adverse event data not reported

Additional Information

David Bush, MD, Vice Chair Clinical Affairs Radiation Medicine

Loma Linda University Health

Phone: 909 558 1000

Email: DBush@llu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place