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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, PreventionActive40 and overZ11102
NCI-2012-00707, ACOSOG-Z11102, CDR0000728605, NCT01556243

Trial Description


This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with breast cancer with two or more tumors in the same breast (multiple ipsilateral). 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.

Further Study Information


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


I. 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.

II. 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.

III. To assess patient’s perception of cosmesis and incidence of breast lymphedema.

IV. To assess incidence of breast lymphedema.

V. To examine the type and severity of adverse effects of breast conserving surgery and radiation for women with multiple ipsilateral primary breast cancer (MIBC).

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


I. 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.

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


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. Within 12 weeks following surgery, 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) 5 days a week for approximately 6 weeks.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Eligibility Criteria

Inclusion Criteria:

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

Upon clinical exam and pre-operative imaging by mammogram +/- MRI, 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: the shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained; Note: patient is eligible for study if lesion is not visualized on all 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 +/- MRI only; fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy; patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion

Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met:

An area of atypia > 2 cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC OR

Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathology

Bilateral mammogram =< 90 days prior to date of surgery; Note: for patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment

cN0 or cN1 disease

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

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

Ability to provide written informed consent

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

Exclusion Criteria:

Any of the following:

Pregnant women

Nursing women

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

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 1 centimeter of the index lesion

Surgical axillary staging procedure prior to first definitive breast operation; Note: fine-needle aspiration (FNA) or core needle biopsy of axillary node is permitted

Clinical or radiographic evidence of metastatic disease

Prior history of ipsilateral breast cancer (DCIS, LCIS [lobular cancer in situ] or invasive)

cNX, cN2, or cN3 disease

Breast implants at time of diagnosis; Note: patients who have had implants previously removed prior to diagnosis are eligible

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)

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

Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed)

Treatment including radiation therapy, chemotherapy, biotherapy, or hormonal therapy for this cancer prior to surgery (i.e., any neoadjuvant chemotherapy or endocrine therapy is not allowed); patients who undergo surgical resection with breast conservation and then are treated with adjuvant systemic therapy are eligible to enroll prior to the start of radiotherapy

Planned partial breast radiation

Patients with known breast cancer (BRCA) mutations; patients who are not tested or whose testing result is not returned at the time of registration are not excluded from registering to this study

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Alliance for Clinical Trials in Oncology

  • National Cancer Institute
Judy C. Szemere Boughey, Principal Investigator

Trial Sites


South Bend

Northern Indiana Cancer Research Consortium

Robin T. Zon
Ph: 574-234-5123

Robin T. Zon
Principal Investigator

Des Moines

Iowa-Wide Oncology Research Coalition NCORP

Robert J. Behrens
Ph: 515-282-2921

Robert J. Behrens
Principal Investigator


Cancer Trials Support Unit

Judy C. Szemere Boughey

Judy C. Szemere Boughey
Principal Investigator


Montana Cancer Consortium NCORP

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

Las Vegas

Nevada Cancer Research Foundation CCOP

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

Link to the current record.
NLM Identifier NCT01556243

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the record via the link above for more information about participating sites.