Primary Breast Cancer Occurring Concomitant With Pregnancy

Overview[ - collapse ][ - ]

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.
ConditionBreast Cancer
Pregnancy
InterventionDrug: 5-Fluorouracil
Drug: Cyclophosphamide
Drug: Doxorubicin
PhaseN/A
SponsorM.D. Anderson Cancer Center
Responsible PartyM.D. Anderson Cancer Center
ClinicalTrials.gov IdentifierNCT00510367
First ReceivedJuly 31, 2007
Last UpdatedMarch 19, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateJuly 31, 2007
Last Updated DateMarch 19, 2014
Start DateAugust 2001
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresResults 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]
Current Secondary Outcome MeasuresOutcome 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]

Descriptive Information[ + expand ][ + ]

Brief TitlePrimary Breast Cancer Occurring Concomitant With Pregnancy
Official TitleMultimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy
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.
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 TypeInterventional
Study PhaseN/A
Study DesignEndpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Breast Cancer
  • Pregnancy
InterventionDrug: 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
Study Arm (s)Experimental: Multimodality Treatment
Multimodality (chemotherapy, surgery and radiation therapy) treatment:
5-Fluorouracil + Doxorubicin + Cyclophosphamide (FAC)

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment100
Estimated Completion DateNot Provided
Estimated Primary Completion DateAugust 2016
Eligibility 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.
GenderFemale
AgesN/A
Accepts Healthy VolunteersNo
ContactsContact: Jennifer Litton, MD
713-792-2817
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00510367
Other Study ID NumbersID01-193
Has Data Monitoring CommitteeNo
Information Provided ByM.D. Anderson Cancer Center
Study SponsorM.D. Anderson Cancer Center
CollaboratorsNot Provided
Investigators Principal Investigator: Jennifer Litton, MD M.D. Anderson Cancer Center
Verification DateMarch 2014

Locations[ + expand ][ + ]

UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Principal Investigator: Jennifer Litton, MD
Recruiting