Trial Information

Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy

Patients in this study will be evaluated by the Department of Breast Medical Oncology
attending physician and the obstetrician. Patients who do not have an obstetrician will be
referred to an obstetrician or Maternal-Fetal Medicine specialist for evaluation.

Counseling about primary breast cancer risks, staging evaluation, and breast cancer
management will be provided by members of the Department of Breast Medical Oncology.
Counseling about fetal health risks will be provided by the medical oncologists and the
obstetrician or the Maternal-Fetal Medicine Specialist. Counseling about surgical risks
will be provided by the Breast Surgical Service. Evaluation will include a medical history
and physical exam. Doctors will be evaluating patients especially for the presence of
metastatic disease. The date of the last menstrual period and estimated date of delivery
will be recorded.

Patients in this study will have a chest radiograph with appropriate fetal shielding.
Patients will have an ultrasound of the abdomen to evaluate the presence or absence of
metastatic disease in the liver. If suspicious abnormalities are found, a MRI of the
abdomen will be done. Scanning MRI of the thoracic spine will be performed to screen for
bone metastases. Patients will have standard blood tests and a mammogram or ultrasound of
the affected breast and lymph node bearing areas. Patients will have a tissue biopsy to
confirm the status of the cancer. An ultrasound will also be performed to learn the age and
development of the fetus.

Patients with operable primary breast cancer tumors will have surgical evaluation for
surgical therapy with modified radical mastectomy or segmental mastectomy with lymph node
dissection.

Patients with locally advanced breast cancers will receive systemic multi-agent chemotherapy
in the presurgical setting.

Patients will have physical exams, mammograms, and ultrasounds repeated to evaluate tumor
response to treatment. All patients who will receive chemotherapy will be offered systemic
chemotherapy with 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC).

Patients will be followed 6-12 months using the American Society of Clinical Oncology
Guidelines and the Surveillance Committee Guidelines. All children will be followed until
their adulthood. If the disease gets worse, patients will be treated off the study with
individualized therapy. Premedication will be provided for all patients in order to
decrease the risks of nausea and vomiting. When needed, adjustment in dosage of
chemotherapy or modification in the way the medicines are given will be made in order to
decrease any side effects.

This is an investigational study. The FDA has approved the study drugs. Their use together
in this study is experimental. At least 100 patients will take part in this study. All
will be enrolled at MD Anderson.