Primary Breast Cancer Occurring Concomitant With Pregnancy

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00510367

Collaborator

(none)

Enrollment

Location

Arm

227

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to learn the results of multimodality (chemotherapy, surgery and radiation therapy) treatment of primary breast cancer that occurs at the same time as pregnancy. Researchers want to evaluate the outcome of labor and delivery as well as evaluate the long-term health outcomes of children exposed to chemotherapy while in their mother's womb.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Pregnancy	Drug: 5-Fluorouracil Drug: Cyclophosphamide Drug: Doxorubicin	Early Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy

Actual Study Start Date :

Aug 7, 2001

Actual Primary Completion Date :

Jul 8, 2020

Actual Study Completion Date :

Jul 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multimodality Treatment Multimodality (chemotherapy, surgery and radiation therapy) treatment: 5-Fluorouracil + Doxorubicin + Cyclophosphamide (FAC)	Drug: 5-Fluorouracil 500 mg/m^2 By Vein Daily x 2 Days Other Names: 5-FU Adrucil Efudex Drug: Cyclophosphamide 500 mg/m^2 By Vein On Day 1 Other Names: Cytoxan Neosar Drug: Doxorubicin 50 mg/m^2 By Vein Over 72 Hours Other Names: AD Hydroxydaunomycin hydrochloride Adriamycin Rubex

Arm

Intervention/Treatment

Experimental: Multimodality Treatment

Multimodality (chemotherapy, surgery and radiation therapy) treatment: 5-Fluorouracil + Doxorubicin + Cyclophosphamide (FAC)

Drug: 5-Fluorouracil

500 mg/m^2 By Vein Daily x 2 Days

Other Names:

5-FU

Adrucil

Efudex

Drug: Cyclophosphamide

500 mg/m^2 By Vein On Day 1

Other Names:

Cytoxan

Neosar

Drug: Doxorubicin

50 mg/m^2 By Vein Over 72 Hours

Other Names:

Hydroxydaunomycin hydrochloride

Adriamycin

Rubex

Outcome Measures

Primary Outcome Measures

Response of Multimodality (Chemotherapy, Surgery and Radiation Therapy) Treatment of Primary Breast Cancer in Pregnant Participants [4 months]
Ultrasound obtained after four cycles of neoadjuvant chemotherapy to assess response.

Secondary Outcome Measures

Outcome of Children Exposed to Chemotherapy While in Their Mother's Womb [Health assessments performed until child reaches the age of 18.]
Health outcomes of children exposed to chemotherapy in utero documented by survey.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

· All patients with primary breast cancer occurring during pregnancy will be eligible for enrollment.

Exclusion Criteria:

Patients presenting with systemic metastases at time of diagnosis.
Patients unwilling or unable to give informed consent.
Patients who have received radiation therapy while pregnant
Patients who have received chemotherapy during the first trimester of pregnancy or chemotherapy other than FAC.