Clinical Trials /

APBI Proton Feasibility and Phase II Study



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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting



Trial Eligibility



  • Brief Title: APBI Proton Feasibility and Phase II Study

Clinical Trial IDs

  • ORG STUDY ID: UPCC 04113
  • NCT ID: NCT01839838


  • Stage IA-IIA Breast Cancer


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.

Detailed Description

      The purpose of the APBI Proton Therapy study is to examine the feasibility, side effects, and
      clinical efficacy of using proton therapy on only the tumor bed of women being treated for
      breast cancer after surgical removal of malignancy (as opposed to whole breast treatment).
      The study's aim is to establish the effects of this type of therapy as it compares to both
      traditional radiation and whole breast treatment therapies. In order to be eligible, the
      patient must be a female older than 50 with either invasive ductal, medullary, papillary,
      colloid (mucinous) or tubular histologies of stage IA-IIA breast cancer, ECOG performance
      status of 0-2, have margins of greater than or equal to 2mm, be node negative or have only
      microscopic node disease, have estrogen- or progesterone-positive breast cancer, and other
      eligibility criteria must be met that is more detailed to describe herein.

Trial Arms

APBI with protonsExperimental

    Eligibility Criteria

            Inclusion Criteria:
              -  Histologically confirmed diagnosis of invasive or non-invasive breast cancer.
              -  Invasive ductal, medullary, papillary, colloid (mucinous) or tubular histologies.
              -  AJCC T1 or T2; N0 or N1mic; Stage IA-IIA breast cancer or AJCC TIS (Stage 0) ductal
                 carcinoma in situ without invasion
              -  Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm
                 or less. (Patients with microscopic multifocality are eligible as long as total
                 pathological size is 3 cm or less).
              -  Estrogen and/or progesterone receptor positive invasive breast cancer. DCIS stage 0
                 does not require receptor testing.
              -  No evidence of distant metastatic disease as documented by history and physical
                 examination (radiographic staging only to be performed as indicated by symptoms or
                 physical findings.)
              -  Patients must have an ECOG Performance Status of 0, 1 or 2
              -  Age ≥ 50.
              -  Patients must be able to provide informed consent.
              -  Patients must have undergone breast-conserving surgery
              -  All tumors (invasive and non-invasive disease) must be excised with a minimum margin
                 width of ≥ 2 mm. Re-excision of surgical margins is permitted. Focally close (<2 mm)
                 or positive (tumor cells at the inked edge of the specimen) margins determined to be
                 at an anatomic boundary of resection by the surgeon, such as posterior fascia for
                 posterior margins or skin for anterior margins, are also acceptable.
              -  Patients with invasive breast cancer must be node-negative (N0) or have only
                 microscopic disease (≤2mm) in the nodes (N1mi). Patients with Stage IA - IIA are
                 required to have axillary staging but it will not be done for patients with Stage 0
                 DCIS. Options for axillary staging include:
                   1. Negative sentinel lymph node biopsy (SLNB)
                   2. Level I-II axillary lymph node dissection (ALND) (6 or more nodes removed).
                   3. Positive SLNB followed by completion ALND (6 or more nodes removed).
              -  Patients presenting with abnormal microcalcifications on a screening mammogram must
                 have radiographically confirmed excision of the suspicious microcalcifications, either
                 by specimen radiograph or post-biopsy mammograms.
              -  The patient must be enrolled on the study within 50 days following the last surgery
                 for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure).
              -  The target lumpectomy cavity must be clearly delineated and the target lumpectomy
                 cavity/whole breast reference volume must be ≤ 30% based on the
                 postoperative/pre-enrollment CT scan.
              -  Patients must have bilateral mammogram and/or breast MRI within 3 months of diagnosis
                 of their breast cancer.
              -  CBC/differential obtained within 3 months prior to registration on study, with
                 adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥
                 1,800 cells/mm3; Platelets ≥ 75,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (Note: The use of
                 transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable).
              -  Patients with synchronous bilateral breast cancers who will be treated with
                 radiotherapy to each breast are eligible, provided such treatment can be performed in
                 a manner that avoids overlap between treatment fields. Both sides may be treated with
                 APBI if the pathologic eligibility criteria are met for both tumors, or only one side
                 may be treated with APBI if the criteria are met for only one tumor.
              -  Patients with a history of prior breast cancer in the opposite breast are eligible as
                 long as treatment can be performed without overlapping any prior RT fields.
              -  Patients with a history of prior breast cancer in the ipsilateral breast treated with
                 lumpectomy alone (no RT) are eligible as long as the other entry criteria for this
                 study are met.
              -  Patients with a history of non-breast malignancies are eligible as long as they have
                 not received prior radiotherapy to the thoracic region, and have a greater than 2 year
                 interval without evidence of recurrence.
              -  Women of childbearing potential must be non-pregnant and non-lactating and willing to
                 exercise an effective form of birth control during radiation therapy (e.g. oral
                 contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause
                 must be clinically documented.
              -  Patient must provide study-specific informed consent prior to study entry.
            Exclusion Criteria
              -  Male breast cancer
              -  T2 (>3cm), T3, T4, Node positive (other than N1mi), or M1 disease
              -  Lobular or mixed ductal and lobular histology.
              -  Multifocal primary tumor.
              -  Clear delineation of the extent of the lumpectomy cavity is not possible. Prior or
                 simultaneous malignancies within the past two years (other than carcinoma in situ of
                 the cervix, CIS of the colon, melanoma in situ, thyroid cancer, and basal cell or
                 squamous cell carcinoma of the skin).
              -  Any non-axillary sentinel node(s) positive. (Note that intramammary nodes are staged
                 as axillary nodes).
              -  Patients who have had a positive SLNB but decline completion ALND are not eligible.
              -  Patients treated with neoadjuvant chemotherapy are not eligible.
              -  Palpable or radiographically suspicious ipsilateral or contralateral axillary,
                 supraclavicular, infraclavicular, or internal mammary nodes, unless there is
                 histological confirmation that these nodes are negative for tumor.
              -  Suspicious microcalcifications, densities, or palpable abnormalities (in the
                 inpsilateral or contralateral breast) unless these were biopsied and found to be
              -  Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or
                 two or more breast cancers not resectable through a single lumpectomy incision.
              -  Paget's disease of the nipple.
              -  Surgical margins that cannot be microscopically assessed or are positive at
                 pathological evaluation. A focally positive margin determined to be at an anatomic
                 boundary of resection by the surgeon, such as posterior fascia for posterior margins
                 and skin for anterior margins, is also acceptable. If surgical margins are rendered
                 free of disease by re-excision, the patient is eligible.
              -  Breast implants. (Patients who have implants removed are eligible).
              -  Prior ipsilateral breast or thoracic radiation for any condition.
              -  Collagen vascular disease, specifically dermatomyositis with a CPK level above normal
                 or with an active skin rash, systemic lupus erythematosis, or scleroderma.
              -  Pregnant women, women planning to become pregnant and women that are nursing.
              -  Psychiatric or addictive disorders or other conditions that, in the opinion of the
                 investigator, would preclude the patient from meeting the study requirements.
              -  Actively being treated on any other therapeutic research study.
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Number of Adverse Events
    Time Frame:5 years
    Safety Issue:


    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

    Trial Keywords

    • Women
    • age 50 and above
    • with
    • that has been
    • surgically excised

    Last Updated

    April 3, 2020