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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Pregnancy
• Intervention / Treatment: Drug: 5-Fluorouracil; Drug: Cyclophosphamide; Drug: Doxorubicin

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Adriamycin; Rubex; AD; Hydroxydaunomycin hydrochloride

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Jennifer Litton, MD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• The University of Texas M.D.Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2001
• Primary Completion (Actual): July 8, 2020
• Study Completion (Actual): July 8, 2020

Study Registration Dates

• First Submitted: July 31, 2007
• First Submitted That Met QC Criteria: August 1, 2007
• First Posted (Estimate): August 2, 2007

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Breast Cancer; Pregnancy; Cyclophosphamide; Doxorubicin; Cytoxan; Neosar; 5-Fluorouracil; Adriamycin; 5-FU; Rubex; FAC; Adrucil; Efudex
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Fluorouracil; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: ID01-193; NCI-2012-01578 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No