Clinical trial NCT00909909: Radiation Therapy in Treating Women With Early Stage Breast Cancer
Official title: Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
invasive ductal breast carcinoma
invasive lobular breast carcinoma
medullary ductal breast carcinoma with lymphocytic infiltrate
mucinous ductal breast carcinoma
papillary ductal breast carcinoma
tubular ductal breast carcinoma
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2009-05-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.

Detailed description: OBJECTIVES:

Primary

* To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
* To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.

Secondary

* To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
* To identify co-variates responsible for poor cosmetic outcome in these patients.

OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.

* Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4 fractions). Beginning 5-21 days after completion of brachytherapy, patients undergo AWBI once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
* 3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or after boost radiotherapy.
* Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated chest wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11 fractions).

Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.

After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer, including 1 of the following subtypes:

  * Ductal carcinoma in situ
  * Invasive ductal carcinoma
  * Invasive lobular carcinoma
  * Medullary carcinoma
  * Papillary carcinoma
  * Colloidal (mucinous) carcinoma
  * Tubular carcinoma
* Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)

  * Tumor size ≤ 5 cm
* Breast considered technically satisfactory for radiotherapy
* Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)

  * Negative inked histological margins (i.e., no invasive cells at surgical margin) or confirmed negative re-excision specimen
* Unifocal or multifocal (confined to 1 quadrant; tumors \< 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy
* No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
* No evidence of suspicious microcalcifications in the breast before the start of radiotherapy

  * If malignancy-associated microcalcifications were initially present, the post-excision mammography must be negative
* No more than 9 positive axillary lymph nodes
* No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
* No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
* No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma)
* No Paget disease of the nipple
* No skin involvement, regardless of tumor size
* No distant metastases
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Pre- or post-menopausal
* ECOG performance status 0-1
* No co-existing medical condition that would limit life expectancy to \< 2 years
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except for nonmelanoma skin cancer (the disease-free interval from any prior malignancy must be continuous)
* No collagen vascular disease, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
* No psychiatric or addictive disorder that would preclude obtaining informed consent

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radiotherapy for the current breast cancer
* No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy
* Chemotherapy allowed provided the following criteria are met:

  * Chemotherapy is not administered prior to, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving brachytherapy boost)
  * Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving external beam radiotherapy boost or chest wall irradiation)
* Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed

  * May be initiated before, during, or after radiotherapy
* No other concurrent chemotherapy, immunotherapy, or experimental medications

Primary outcomes:
measure: Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
timeFrame: 5 years
Secondary outcomes:
measure: Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0
timeFrame: 5 years
measure: Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale
timeFrame: 5 years
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Somerset
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Bruce Haffty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahlawat S, Haffty BG, Goyal S, Kearney T, Kirstein L, Chen C, Moore DF, Khan AJ. Short-Course Hypofractionated Radiation Therapy With Boost in Women With Stages 0 to IIIa Breast Cancer: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2016 Jan 1;94(1):118-125. doi: 10.1016/j.ijrobp.2015.09.011. Epub 2015 Sep 16.