Trial Outcomes & Findings for APBI Proton Feasibility and Phase II Study (NCT NCT01839838)

Last Updated: 2024-11-07

Results Overview

Number of Participants that meets the criteria of feasibility and acute toxicity will be reported. The objectives were both feasibility and acute toxicity profile of accelerated partial breast radiation using protons. Feasibility was based on multiple radiation planning and treatment parameters: (1) a patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised; (2) a patient is unable to tolerate more than 20% of treatments using proton RT (ie, \>2 of the 10 fractions); and/or (3) a patient is unable to complete all treatment within 5 days of the estimated date of treatment completion or requires a treatment break of greater than 5 days. A feasibility rate \>90% was needed to proceed to the phase 2 portion. Outcomes measured and reported were: late toxicity was "% of participants with grade 3 or higher late toxicity"

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

40 participants

Primary outcome timeframe

2 years

Results posted on

2024-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 The phase 1 portion determined feasibility based on criteria of successful plan creation, treatment delivery, and acute toxicity grade ≥3 in ≤20% of patients.	Phase 2 The phase 2 portion had efficacy goals of acute toxicity grade ≥3 in ≤20% of patients and observing physician-rated cosmesis of excellent or good \>85% of patients at 2 years.
Overall Study STARTED	12	28
Overall Study COMPLETED	12	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 n=12 Participants The phase 1 portion determined feasibility based on criteria of successful plan creation, treatment delivery, and acute toxicity grade ≥3 in ≤20% of patients.	Phase 2 n=28 Participants The phase 2 portion had efficacy goals of acute toxicity grade ≥3 in ≤20% of patients and observing physician-rated cosmesis of excellent or good \>85% of patients at 2 years.	Total n=40 Participants Total of all reporting groups
Age, Continuous	64 years n=12 Participants	69 years n=28 Participants	68 years n=40 Participants
Sex: Female, Male Female	12 Participants n=12 Participants	28 Participants n=28 Participants	40 Participants n=40 Participants
Sex: Female, Male Male	0 Participants n=12 Participants	0 Participants n=28 Participants	0 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 2 years

Population: The objectives were both feasibility (A feasibility rate \>90%) and acute toxicity (no more than 20% of patients experiencing an acute grade 3 or higher toxicity).

Outcome measures

Outcome measures
Measure	Phase 1 n=12 Participants The phase 1 portion determined feasibility based on criteria of successful plan creation, treatment delivery, and acute toxicity grade ≥3 in ≤20% of patients.	Phase 2 n=40 Participants Assessment of late Toxicity and Cosmetic outcome
Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons Feasibility	11 Participants	0 Participants
Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons Acute Toxicity	0 Participants	0 Participants
Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons Late Toxicity	—	2 Participants
Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons Cosmesis at 2 years	0 Participants	30 Participants

Adverse Events

APBI With Protons Phase 1

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

APBI With Protons Phase 2

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Gary Freedman, MD

Hospital of the University of Pennsylvania

Phone: 215-615-6767

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	APBI With Protons Phase 1 n=12 participants at risk The period from initiating any study procedures.The secondary outcome from the protocol was late toxicity and cosmesis of accelerated partial breast radiation using protons. There were 12 patients enrolled in this portion	APBI With Protons Phase 2 n=28 participants at risk The period from initiating any study procedures, including both study phases from April 2013 to December 2019. The secondary outcome from the protocol was late toxicity and cosmesis of accelerated partial breast radiation using protons. There were 28 patients enrolled in this portion plus the 12 from the PHASE 1.
Cardiac disorders Chest pain	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.	0.00% 0/28 • 5 years The number recorded will be number and % of patients found to have adverse events.
Cardiac disorders Acute coronary syndrome	8.3% 1/12 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.	0.00% 0/28 • 5 years The number recorded will be number and % of patients found to have adverse events.
Cardiac disorders Atrial fibrillation	8.3% 1/12 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.	0.00% 0/28 • 5 years The number recorded will be number and % of patients found to have adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 1/12 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.	0.00% 0/28 • 5 years The number recorded will be number and % of patients found to have adverse events.
Infections and infestations Enterocolitis infectious	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Vascular disorders Hypertension	8.3% 1/12 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.	0.00% 0/28 • 5 years The number recorded will be number and % of patients found to have adverse events.
Nervous system disorders Intracranial hemorrhage	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
General disorders Multi-organ failure	8.3% 1/12 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.	0.00% 0/28 • 5 years The number recorded will be number and % of patients found to have adverse events.
General disorders Non-cardiac chest pain	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Infections and infestations Sepsis	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Gastrointestinal disorders Small intestine ulcer	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Nervous system disorders Syncope	8.3% 1/12 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.

Measure	APBI With Protons Phase 1 n=12 participants at risk The period from initiating any study procedures.The secondary outcome from the protocol was late toxicity and cosmesis of accelerated partial breast radiation using protons. There were 12 patients enrolled in this portion	APBI With Protons Phase 2 n=28 participants at risk The period from initiating any study procedures, including both study phases from April 2013 to December 2019. The secondary outcome from the protocol was late toxicity and cosmesis of accelerated partial breast radiation using protons. There were 28 patients enrolled in this portion plus the 12 from the PHASE 1.
General disorders Breast edema	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Reproductive system and breast disorders Breast pain	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Skin and subcutaneous tissue disorders Breast pigment change	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Skin and subcutaneous tissue disorders burning sensation of skin	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Injury, poisoning and procedural complications Dermatitis radiation	25.0% 3/12 • Number of events 3 • 5 years The number recorded will be number and % of patients found to have adverse events.	7.1% 2/28 • Number of events 2 • 5 years The number recorded will be number and % of patients found to have adverse events.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	7.1% 2/28 • Number of events 2 • 5 years The number recorded will be number and % of patients found to have adverse events.
General disorders Fatigue	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	7.1% 2/28 • Number of events 2 • 5 years The number recorded will be number and % of patients found to have adverse events.
Musculoskeletal and connective tissue disorders Fibrosis of breast	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	7.1% 2/28 • Number of events 2 • 5 years The number recorded will be number and % of patients found to have adverse events.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	7.1% 2/28 • Number of events 2 • 5 years The number recorded will be number and % of patients found to have adverse events.
Reproductive system and breast disorders Breast tenderness	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
Injury, poisoning and procedural complications Fracture	0.00% 0/12 • 5 years The number recorded will be number and % of patients found to have adverse events.	3.6% 1/28 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.
General disorders Localized edema	16.7% 2/12 • Number of events 2 • 5 years The number recorded will be number and % of patients found to have adverse events.	28.6% 8/28 • Number of events 8 • 5 years The number recorded will be number and % of patients found to have adverse events.
Skin and subcutaneous tissue disorders Pruritus	8.3% 1/12 • Number of events 1 • 5 years The number recorded will be number and % of patients found to have adverse events.	7.1% 2/28 • Number of events 2 • 5 years The number recorded will be number and % of patients found to have adverse events.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	16.7% 2/12 • Number of events 2 • 5 years The number recorded will be number and % of patients found to have adverse events.	60.7% 17/28 • Number of events 17 • 5 years The number recorded will be number and % of patients found to have adverse events.
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	58.3% 7/12 • Number of events 7 • 5 years The number recorded will be number and % of patients found to have adverse events.	10.7% 3/28 • Number of events 3 • 5 years The number recorded will be number and % of patients found to have adverse events.
Skin and subcutaneous tissue disorders Telangiectasia	50.0% 6/12 • Number of events 6 • 5 years The number recorded will be number and % of patients found to have adverse events.	28.6% 8/28 • Number of events 9 • 5 years The number recorded will be number and % of patients found to have adverse events.