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

Location:

Rochester, MN.

Trial status:

Open for Enrollment

Why is this study being done?

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 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 examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site.

       -  To evaluate protein and gene expression patterns in tissue taken from each breast lesion and to evaluate the concordance of the findings between these lesions.

       -  To compare the extent of disease described on imaging (mammography, bilateral breast magnetic resonance imaging [MRI] and other adjunctive imaging modalities) with surgical findings.

     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.

     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.

     Formalin-fixed paraffin-embedded (FFPE) tissue block from each site of disease are collected during BCS for protein and gene expression pattern studies. Blood samples may be also collected at baseline and during BCS.

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

Who is eligible to participate?

DISEASE CHARACTERISTICS:

         -  Upon clinical exam and pre-operative imaging by MRI and mammogram both, two or three foci of biopsy-proven breast cancer separated by ≥ 3 cm of normal breast tissue on clinical exam and preoperative imaging; 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-positive breast cancer

              -  Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram and MRI only

         -  Bilateral mammogram ≤ 60 days prior to registration

         -  Bilateral breast MRI ≤ 45 days prior to registration

         -  cN0 or cN1 disease

              -  No cNX, cN2, or cN3 disease

         -  Willing to provide tissue samples for correlative research purposes

         -  Largest single focus of disease > 5 cm by either mammogram or MRI or both (measurement of the largest single focus should include any satellite lesions within 1 cm of the index lesion)

         -  No clinical or radiographic evidence of metastatic disease

         -  No prior or current lobular carcinoma in situ (LCIS), DCIS, or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed)

         -  No patients with known BRCA mutations

       PATIENT CHARACTERISTICS:

         -  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)

         -  Men are excluded from this study

         -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

         -  Hemoglobin (Hgb) ≥ 8 g/dL

         -  Peripheral platelet count (PLT) ≥ 50,000/mm³

         -  Ability to complete questionnaire(s) by themselves or with assistance

         -  Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study

         -  Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only

         -  None of the following:

              -  Pregnant women

              -  Nursing women

              -  Women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)

         -  No 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, or scleroderma)

         -  No 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

         -  No other active malignancy ≤ 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix

              -  If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer

       PRIOR CONCURRENT THERAPY:

         -  No surgical axillary staging procedure prior to study entry

              -  Fine-needle aspiration (FNA) or core-needle biopsy of axillary node is permitted

         -  No breast implants at time of diagnosis

              -  Patients who have had implants previously removed prior to diagnosis are eligible

         -  No treatment including radiation therapy, chemotherapy, biotherapy, or hormonal therapy for this cancer prior to registration

         -  No neoadjuvant endocrine therapy or neoadjuvant hormonal therapy

         -  No planned partial-breast radiation

         -  No administration of any investigational agent ≤ 30 days prior to registration

Last updated:

1/30/2013

NCT ID:

NCT01556243

IRB Number:

12-000943