Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Radiation Therapy in Treating Women With Early Stage Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Rutgers, The State University of New Jersey
Sponsor:
Collaborators:
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00909909
First received: May 28, 2009
Last updated: September 26, 2014
Last verified: September 2014

May 28, 2009
September 26, 2014
May 2009
June 2015   (final data collection date for primary outcome measure)
Loco-regional control as assessed by physical examination, mammography, and other relevant imaging [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Loco-regional control as assessed by physical examination, mammography, and other relevant imaging [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00909909 on ClinicalTrials.gov Archive Site
  • Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale (patient-rated) at baseline and at 3 years, the Harvard cosmesis scale (physician-rated) at baseline and at 1 and 3 years, and by frontal digital photography of the breasts at baselin ... [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Radiation Therapy in Treating Women With Early Stage Breast Cancer
Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Radiation: External beam boost
    3-dimensional conformal radiation therapy and intensity modulated radiation therapy
  • Radiation: whole breast irradiation
    accelerated, hypofractionated whole breast irradiation
  • Active Comparator: A
    3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI)
    Interventions:
    • Radiation: External beam boost
    • Radiation: whole breast irradiation
  • Active Comparator: B
    Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost
    Interventions:
    • Radiation: External beam boost
    • Radiation: whole breast irradiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2016
June 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Clinical Trials Office 732-235-8675
United States
 
NCT00909909
040807, CDR0000643276, P30CA072720, 0220090059
Yes
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey
Principal Investigator: Atif Khan, MD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP