Primary Breast Cancer Occurring Concomitant With Pregnancy

This study is currently recruiting participants.
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00510367
First received: July 31, 2007
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention
Breast Cancer
Pregnancy
Drug: 5-Fluorouracil
Drug: Cyclophosphamide
Drug: Doxorubicin

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Results of multimodality (chemotherapy, surgery and radiation therapy) treatment of primary breast cancer that occurs at the same time as pregnancy. [ Time Frame: 9 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 9 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2001
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510367

Contacts
Contact: Jennifer Litton, MD 713-792-2817

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jennifer Litton, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jennifer Litton, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00510367     History of Changes
Other Study ID Numbers: ID01-193, NCI-2012-01578
Study First Received: July 31, 2007
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
FAC
Doxorubicin
Adriamycin
Rubex
5-Fluorouracil
5-FU
Adrucil
Efudex
Cyclophosphamide
Cytoxan
Neosar
Pregnancy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on April 15, 2014