NCT01839838

APBI Proton Feasibility and Phase II Study

Completed Phase 1, PHASE2 Results posted Last updated 7 November 2024

What this trial tests

Phase 1, PHASE2 trial testing Proton Therapy in Stage IA-IIA Breast Cancer in 40 participants. Completed in 23 December 2022.

Timeline

22 April 2013

Primary endpoint
23 December 2022

23 December 2022

Quick facts

Lead sponsor	Abramson Cancer Center at Penn Medicine
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	22 April 2013
Primary completion	23 December 2022
Estimated completion	23 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Proton Therapy

Conditions studied

• Stage IA-IIA Breast Cancer — all drugs for Stage IA-IIA Breast Cancer →

Sponsor

Abramson Cancer Center at Penn Medicine — full company profile →

Who can join

50 and older, female only, with Stage IA-IIA Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons Primary · 2 years

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 wi

Feasibility

Group	Value	95% CI
Phase 1	11
Phase 2	0

Acute Toxicity

Group	Value	95% CI
Phase 1	0
Phase 2	0

Late Toxicity

Group	Value	95% CI
Phase 2	2

Cosmesis at 2 years

Group	Value	95% CI
Phase 1	0
Phase 2	30

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

APBI With Protons Phase 1

Serious: 4/12 (33%)

Deaths: 0/12

APBI With Protons Phase 2

Serious: 7/28 (25%)

Deaths: 0/28

Serious adverse events (16 terms)

Reaction	System	APBI With Protons Phase 1	APBI With Protons Phase 2
Chest pain	Cardiac disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Acute coronary syndrome	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Enterocolitis infectious	Infections and infestations	—	—
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	—	—
Hypertension	Vascular disorders	—	—
Intracranial hemorrhage	Nervous system disorders	—	—
Multi-organ failure	General disorders	—	—
Non-cardiac chest pain	General disorders	—	—
Reproductive system and breast disorders - Other, specify	Reproductive system and breast disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Sepsis	Infections and infestations	—	—
Small intestine ulcer	Gastrointestinal disorders	—	—
Syncope	Nervous system disorders	—	—

Other adverse events (17 terms — click to expand)

Reaction	System	APBI With Protons Phase 1	APBI With Protons Phase 2
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	—	—
Localized edema	General disorders	—	—
Telangiectasia	Skin and subcutaneous tissue disorders	—	—
Superficial soft tissue fibrosis	Musculoskeletal and connective tissue disorders	—	—
Dermatitis radiation	Injury, poisoning and procedural complications	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Fatigue	General disorders	—	—
Fibrosis of breast	Musculoskeletal and connective tissue disorders	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Breast edema	General disorders	—	—
Breast pain	Reproductive system and breast disorders	—	—
Breast pigment change	Skin and subcutaneous tissue disorders	—	—
burning sensation of skin	Skin and subcutaneous tissue disorders	—	—
Breast tenderness	Reproductive system and breast disorders	—	—
Skin hypopigmentation	Skin and subcutaneous tissue disorders	—	—
Fracture	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Chest pain, Abdominal pain, Acute coronary syndrome, Atrial fibrillation, Dyspnea, Enterocolitis infectious, Generalized muscle weakness, Hypertension.

Data from ClinicalTrials.gov NCT01839838 adverse events section.

Sponsor's own description

The overall objectives of the study are to establish feasibility and acute side effects of accelerated partial breast irradiation therapy, along with more long-term side effects and clinical efficacy of treatment.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proton beam therapy for cancer in the era of precision medicine.
   Hu M, Jiang L, Cui X, Zhang J, et al · · 2018 · cited 57× · PMID 30541578 · DOI 10.1186/s13045-018-0683-4
2. Proton Therapy in Breast Cancer: A Review of Potential Approaches for Patient Selection.
   Wu XY, Chen M, Cao L, Li M, et al · · 2024 · cited 3× · PMID 38389426 · DOI 10.1177/15330338241234788
3. Five-Year Outcomes of a Phase 1/2 Trial of Accelerated Partial Breast Irradiation Using Proton Therapy for Women With Stage 0-IIA Breast Cancer.
   Freedman GM, Li T, Garver E, Shillington K, et al · · 2024 · cited 2× · PMID 38405317 · DOI 10.1016/j.adro.2023.101334