Selective Use of Observation in HER-2 Positive Breast Cancer Participants Who Have Undergone Lumpectomy and Lymph Node Biopsy and Achieved Pathologic Complete Response after Chemotherapy

Status: closed to accrual

This trial studies selective use of observation in HER-2 positive breast cancer participants who have undergone lumpectomy and lymph node biopsy and have achieved pathologic complete response after chemotherapy. Radiation can help to reduce recurrence in the majority of patients with breast cancer. However, radiation can have many side effects, such as sunburn of the breast, changes in breast shape, damage to the lungs, damage to the heart, and secondary cancers related to radiation. Examining selective use of observation may help doctors determine the rates of recurrence in the breast or elsewhere in the body for HER-2 positive patients who have no evidence of cancer at the time of surgery after prior treatment with chemotherapy and other targeted medicines.

Inclusion Criteria

ENROLLMENT: Ability of participant to understand this study, and participant willingness to sign a written informed consent
ENROLLMENT: Women 40 years of age or older with a diagnosis of invasive ductal or lobular carcinoma
ENROLLMENT: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
ENROLLMENT: Must be HER2-positive in primary breast tumor by the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2013
ENROLLMENT: cT1-2N0 on clinical staging (verified to have no suspicious axillary or internal mammary nodes on magnetic resonance imaging [MRI] or ultrasound)
ENROLLMENT: Measurable disease by Response Criteria in Solid Tumors (RECIST) 1.1
TREATMENT: Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to initiating treatment
TREATMENT: Undergo neoadjuvant chemotherapy with a trastuzumab based regimen prior to surgery and plan for completion of one year of trastuzumab
TREATMENT: Patients are required to undergo lumpectomy with sentinel lymph node biopsy
TREATMENT: Pathologic review shows no evidence of residual disease in the tumor bed (to also include no evidence of residual ductal carcinoma in situ [DCIS])
TREATMENT: Tumor bed should be no larger than 5 cm in size on pathologic review
TREATMENT: Fibrotic area of prior tumor located at least 3 mm away from surgical margins
TREATMENT: No evidence of treatment related change in the lymph nodes on pathologic review
TREATMENT: Leukocytes >= 1.5K/UL
TREATMENT: Absolute neutrophil count (ANC) >= 1.5K/UL * NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient
TREATMENT: Platelets >= 100K/UL
TREATMENT: Hemoglobin >= 9 g/dL
TREATMENT: Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation
TREATMENT: Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN
TREATMENT: Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
TREATMENT: Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for XX months following completion of therapy

Exclusion Criteria

Simultaneously enrolled in any therapeutic clinical trial
Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
Is pregnant or breastfeeding
Diagnosis of inflammatory breast cancer
Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more)
Diagnosis of metastatic disease

PRIMARY OBJECTIVE:

I. To describe local control rate in patients with her-2 positive early stage breast cancers with a complete response to chemotherapy and lumpectomy alone.

SECONDARY OBJECTIVES:

I. To determine rates of regional recurrences in patients with omission of whole breast radiation.

II. To determine rates of distant metastasis in patients with omission of whole breast radiation.

III. To determine rates of disease free survival in patients with omission of whole breast radiation.

IV. To determine rate of overall survival in patients with omission of whole breast radiation.

V. To assess quality of life using the Functional Assessment of Cancer Therapy Questionnaire-Breast version 4 (FACT-B+4) breast quality of life questionnaire.

VI. To assess cosmesis without radiation to the breast using the Breast Q.

VII. To assess effects of therapy on lymphedema and range of motion.

OUTLINE: After undergoing lumpectomy with lymph node evaluation, participants are assigned to 1 of 3 arms.

ARM A: Participants without evidence of tumor receive routine follow-up.

ARM B: Participants without evidence of tumor receive standard of care radiation.

ARM C: Participants with residual tumor receive standard of care radiation.

After completion of study, participants are followed up at 1, 3, and 6 months and then every 6 months (Arm A) or every 12 months (Arms B and C) for 5 years.

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Selective Use of Observation in HER-2 Positive Breast Cancer Participants Who Have Undergone Lumpectomy and Lymph Node Biopsy and Achieved Pathologic Complete Response after Chemotherapy

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