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Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Women With Stage III,Loco-Regional, Non-Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Breast Neoplasm, Breast Tumor, Cancer of the Breast

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Trial Information

Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Women With Stage III,Loco-Regional, Non-Metastatic Breast Cancer

The proposed Phase II study is seeking to build clinical data as a continuation of the
original dosimetric analysis published by Ares et al. performed at Paul-Scherrer Institute
(PSI). That comparison demonstrated a benefit form proton planning for patients with
non-metastatic breast cancer requiring complex, loco-regional, postoperative radiotherapy.1
The advantages of PT were improved target coverage compared to standard photon irradiation
and reduced dose to heart, lungs and contralateral breast.

The study goal is to demonstrate a "meaningful benefit" of proton therapy for women with
loco-regionally advanced breast cancer. The main clinical endpoints of this trial are the
reduction of cardiac morbidity and mortality (coronary artery disease, myocardial
infarction, cardiac insufficiency) and the reduction of contralateral, second breast cancer.
Both adverse events are presently associated with external beam photon therapy. Both goals
require longitudinal follow-up of minimum 5-10 years. Despite the logistical challenges of
long term follow-up, the effort is needed in view of the compelling preclinical evidence of
dose avoidance or even absence of radiation dose to heart and contralateral breast uniquely
accomplishable by protons only.

Inclusion Criteria:

- Must sign study-specific, institutional review board (IRB) approved informed consent
form prior to study entry. Note consent by legally authorized representative is not
allowed for this trial.

- Must be female.

- Must be > = 18 years of age.

- Must have a life expectancy of at least 10 years based on age and co-morbidities but
excluding diagnosis of breast cancer.

- Must have pathology proven breast cancer. Pathology must be invasive ductal or
lobular carcinoma of the breast.

- Must meet stage III group criteria per American Joint Committee on Cancer (AJCC)
Staging manual 7th edition (see appendix II).

- Must be treated with proton therapy within 9 weeks after last surgery for breast
cancer (lumpectomy, re-excision of margins, axillary staging procedure or mastectomy)
OR if chemotherapy is given, it must be finished at least 2 weeks and not later than
8 weeks prior to PT.

- Must have had surgical treatment of the breast - either modified radical mastectomy
or lumpectomy. Re-excision of surgical margins is permitted.

Exclusion Criteria:

- Weight over 410 pounds.

- Non-epithelial breast malignancies such as sarcoma or lymphoma.

- Synchronous multifocal or bilateral invasive or non-invasive breast cancer.

- Surgical margins that cannot be microscopically assessed or are positive at
pathologic evaluation. (If surgical margins are rendered free of disease by
re-excision, the patient is eligible).

- Evidence of contralateral breast cancer that would require contralateral adjuvant

- Breast size exceeding the technical limitation of daily set-up reproducibility. This
may be center-specific and will be assessed at the discretion of the treating center.

- Women with post-surgical temporary breast expanders will require individual
assessment. Depending on the manufacturing product and other treatment
planning-specific details the patient may be eligible or may be deemed ineligible, as
determined by treating investigator.

- Prior history of breast cancer.

- Paget's disease of the nipple.

- Prior radiation to the breast or thorax.

- Collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase
(CPK)level above normal or with an active skin rash, systemic lupus erythematosis, or

- Pregnancy or lactation at the time of proposed study entry. Women of reproductive
potential must agree to use an effective non-hormonal method of contraception during
therapy such as an intrauterine device or condom with spermicide.

- Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude the patient from meeting the study requirements.

- Prior history of non-breast malignancies unless they have been disease free for 5 or
more years and are deemed by their physician to be at low risk for recurrence.
Further, patients who have the following cancers treated within the prior 5 years are
permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma
in situ, basal cell or squamous cell carcinoma of the skin.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Eugen Hug, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Proton Collaborative Group


United States: Institutional Review Board

Study ID:




Start Date:

February 2013

Completion Date:

January 2030

Related Keywords:

  • Breast Cancer
  • Breast Neoplasm
  • Breast Tumor
  • Cancer of the Breast
  • Breast
  • Cancer
  • Radiation
  • Proton
  • Breast Neoplasms
  • Neoplasms



ProCure Proton Therapy CenterWarrenville, Illinois  60555
ProCure Proton Therapy CenterOklahoma City, Oklahoma  73142
Princeton ProCure Managment LLCSomerset, New Jersey  08873