Primary Breast Cancer Occurring Concomitant With Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510367
Recruitment Status : Active, not recruiting
First Posted : August 2, 2007
Last Update Posted : March 16, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

July 31, 2007
August 2, 2007
March 16, 2018
August 2001
August 2019   (Final data collection date for primary outcome measure)
Response of Multimodality (Chemotherapy, Surgery and Radiation Therapy) Treatment of Primary Breast Cancer in Pregnant Participants [ Time Frame: 4 months ]
Ultrasound obtained after four cycles of neoadjuvant chemotherapy to assess response.
Not Provided
Complete list of historical versions of study NCT00510367 on Archive Site
Outcome of Children Exposed to Chemotherapy While in Their Mother's Womb [ Time Frame: Health assessments performed until child reaches the age of 18. ]
Health outcomes of children exposed to chemotherapy in utero documented by survey.
Not Provided
Not Provided
Not Provided
Primary Breast Cancer Occurring Concomitant With Pregnancy
Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy
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.

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.

Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Pregnancy
  • 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
Experimental: Multimodality Treatment

Multimodality (chemotherapy, surgery and radiation therapy) treatment:

5-Fluorouracil + Doxorubicin + Cyclophosphamide (FAC)

  • Drug: 5-Fluorouracil
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin
Murthy RK, Theriault RL, Barnett CM, Hodge S, Ramirez MM, Milbourne A, Rimes SA, Hortobagyi GN, Valero V, Litton JK. Outcomes of children exposed in utero to chemotherapy for breast cancer. Breast Cancer Res. 2014 Dec 30;16(6):500. doi: 10.1186/s13058-014-0500-0.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
August 2020
August 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
NCI-2012-01578 ( Registry Identifier: NCI CTRP )
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Jennifer Litton, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP