Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01556243
First received: March 15, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer


Condition Intervention Phase
Breast Cancer
Procedure: therapeutic conventional surgery
Radiation: whole breast irradiation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Local recurrence defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years [ Time Frame: Up to 5 years post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conversion rate to mastectomy secondary to persistent positive margins assessed [ Time Frame: Up to 5 years post-treatment ] [ Designated as safety issue: No ]
  • Type and severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
  • Radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site as assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
  • Patient's perception of cosmesis assessed up to 24 months after WBI using the BREAST-Q© scoring module [ Time Frame: Up to 2 years post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: July 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast conservation surgery and radiation therapy
Patients undergo breast conserving surgery with all lesions resected to negative margins using one lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon. Patients receive adjuvant chemotherapy and/or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics. Within 6-10 weeks after surgery or 8 weeks after completion of cytotoxic chemotherapy, patients undergo adjuvant whole breast irradiation with a boost to the lumpectomy bed of each site of disease 5 days per week for approximately 6 weeks.
Procedure: therapeutic conventional surgery Radiation: whole breast irradiation

Detailed Description:

OBJECTIVES:

Primary

  • To assess the local recurrence (LR) rate with breast-conservation in patients with multiple ipsilateral primary breast cancer (MIBC).

Secondary

  • To examine the conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting breast-conservation surgery (BCS) or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.
  • To assess whether patients who did not undergo re-excision for close margins (< 2 mm) have a higher local recurrence (LR) rate than patients for whom negative margins were achieved.
  • To assess patient's perception of cosmesis and incidence of breast lymphedema.
  • To examine the type and severity of adverse effects of BCS and radiation for women with MIBC.
  • To assess incidence of breast lymphedema
  • To examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site.

OUTLINE: This is a multicenter study.

Patients undergo breast-conserving surgery (BCS) with all lesions resected to negative margins using 1 lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon. Patients receive adjuvant chemotherapy and/or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics.

Within 6-10 weeks after surgery or 8 weeks after completion of cytotoxic chemotherapy, patients undergo adjuvant whole-breast irradiation (WBI) with a boost to the lumpectomy bed of each site of disease 5 days a week for approximately 6 weeks at the discretion of the surgeon.

Patients complete the Breast-Conserving Therapy Module (BREAST-Q© subscales) questionnaire 5-30 days after surgery and every 6 months for the first 2 years and the yearly for the next 3 years after WBI. Patients' surgeons also complete the questionnaire 5-30 days after performing final surgery to assess cosmetic outcomes.

After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly for years 3-5.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Registration Inclusion Criteria:

  1. Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation.
  2. Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)
  3. Female Gender - Men are excluded from this study. Male breast cancer is a rare event.

    Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC.

  4. Foci of Breast Cancer - Upon clinical exam and pre-operative imaging by both MRI and mammogram, two or three foci of biopsy proven breast cancer separated by > 2 cm of normal breast tissue. Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS).

    No more than 2 quadrants with biopsy proven breast cancer.

    Note: Patient is eligible for study if lesion is not visualized on both imaging modalities (i.e., any of the lesion(s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI). Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram and MRI only. Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion.

  5. Mammogram Imaging - Bilateral mammogram ≤ 60 days prior to registration
  6. MRI Imaging - Bilateral breast MRI ≤ 60 days prior to registration
  7. Staging of Cancer - cN0 or cN1 disease
  8. ECOG Performance Status (PS) - 0, 1, or 2.

    Note: An ECOG PS scale is available on the Cancer Trial Support Unit (CTSU) website.

  9. Hemoglobin and Platelet Count - The following laboratory values obtained ≤ 21 days prior to registration:

    • Hemoglobin (Hgb) ≥ 8 g/dL
    • Peripheral platelet count (PLT) ≥ 50,000/mm3
  10. Pregnancy for Women of Childbearing Potential - Negative urine or serum pregnancy test result ≤ 7 days prior to registration for women of childbearing potential only.
  11. Ability to Complete Questionnaires by themselves or with assistance.
  12. Ability to Provide Written Informed Consent
  13. Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study. Patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution.

Registration Exclusion Criteria:

  1. Pregnancy, Nursing and Requirement for Contraception Any of the following because this study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects:

    • Pregnant women
    • Nursing women
    • Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)
  2. Size of Single Focus of Disease - Largest single focus of disease > 5 centimeters by either mammogram or MRI or both. Note: Measurement of the largest single focus should include any satellite lesions within 1centimeter of the index lesion.
  3. Prior Staging Procedure - Surgical axillary staging procedure prior to study entry.

    Note: FNA or core needle biopsy of axillary node is permitted.

  4. Evidence of Metastatic Disease - Clinical or radiographic evidence of metastatic disease
  5. Prior history of ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive]
  6. Staging of Cancer - cNX, cN2, or cN3 disease
  7. Breast Implants at time of diagnosis.

    Note: Patients who have had implants previously removed prior to diagnosis are eligible.

  8. Systemic Illnesses or Concurrent Disease - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma).
  9. Uncontrolled Intercurrent Illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  10. Bilateral Breast Cancer Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed).
  11. Disallowed Prior Treatments - Treatment including radiation therapy, chemotherapy, biotherapy, hormonal therapy for this cancer prior to registration.
  12. Chemotherapy or Endocrine Therapy Prior to Surgery - Neoadjuvant chemotherapy or neoadjuvant endocrine therapy (in other words, no chemotherapy or endocrine therapy prior to surgery) for this cancer.
  13. Partial Breast Radiation - Planned partial breast radiation.
  14. Investigational Agents - Administration of any investigational agent ≤ 30 days prior to registration.
  15. Known BRCA Mutations - Patients with known BRCA mutations.
  16. Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.

Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556243

  Show 211 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Judy Boughey, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01556243     History of Changes
Other Study ID Numbers: CDR0000728605, ACOSOG-Z11102
Study First Received: March 15, 2012
Last Updated: November 20, 2013
Health Authority: United States: NCI Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 25, 2014