Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Procedure: therapeutic conventional surgery
  • Radiation: whole breast irradiation

Phase:

Phase 2

Eligibility


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.

   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

   4.1 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.

   4.2 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.

   4.3 Note: The shortest distance between lesions must be reported on mammogram +/- MRI
   and eligibility criteria must be met on both, if both are obtained.

   4.4 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).

   4.5 Ultrasound cannot be used to determine patient eligibility; eligibility to be
   determined by bilateral mammogram +/- MRI only.

   4.6 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.

   4.7 Patient may remain on study if, upon pathological assessment, two or three lesions
   identified on pre-operative imaging represent one contiguous lesion.

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

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

   5.2 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.

   6. Mammogram Imaging - Bilateral mammogram ≤ 90 days prior to date of surgery.

   6.1 Note: For patients undergoing more than 1 breast operation, this is the date of
   the first breast surgery for breast cancer treatment.

   7. Staging of Cancer - cN0 or cN1 disease

   8. ECOG Performance Status (PS) - 0, 1, or 2.

   9. Ability to Complete Questionnaires - Ability to complete questionnaire(s) by
   themselves or with assistance

10. Ability to Provide Written Informed Consent

11. Willing to Return to Enrolling Institution - 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 - Pregnant women, nursing women
   and women of childbearing potential who are unwilling to employ adequate contraception
   (as determined by the treating physician) are excluded from participation.

   This study involves radiation therapy (WBI) that has known genotoxic, mutagenic and
   teratogenic effects.

   2. Size of Single Focus of Disease on Preoperative Imaging - 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.

   3. Prior Staging Procedure - Surgical axillary staging procedure prior to first
   definitive breast operation. 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 Breast Cancer - 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 - 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 - 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 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.

12. Partial Breast Radiation - Planned partial breast radiation.

13. Known BRCA Mutations - Patients with known 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.

14. Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.

14.1 Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.

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

Ages Eligible for Study

40 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting