APBI Proton Feasibility and Phase II Study

NCT01839838 | Completed Phase 1 Results DMC

• 1 other identifier: UPCC 04113
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage IA-IIA Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons

  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"

  2 years

Study Arms (2)

APBI with protons Phase 1

EXPERIMENTAL

Feasibility phase 1

Radiation: Proton Therapy

APBI with protons Phase 2

EXPERIMENTAL

Study phase 2

Radiation: Proton Therapy

Interventions

Proton Therapy RADIATION

APBI with protons Phase 1; APBI with protons Phase 2

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Negative sentinel lymph node biopsy (SLNB)
• Level I-II axillary lymph node dissection (ALND) (6 or more nodes removed).
• Positive SLNB followed by completion ALND (6 or more nodes removed).

You may not qualify if:

• 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 benign.
• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• 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

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Gary Freedman, MD
• Organization: Hospital of the University of Pennsylvania

Gary.freedman@pennmedicine.upenn.edu

215-615-6767

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 25, 2013
• Study Start: April 22, 2013
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-10

Locations

US (1)