Primary Breast Cancer Occurring Concomitant With Pregnancy
Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy
2 other identifiers
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 breast-cancer
Started Aug 2001
Longer than P75 for early_phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2001
CompletedFirst Submitted
Initial submission to the registry
July 31, 2007
CompletedFirst Posted
Study publicly available on registry
August 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2020
CompletedJuly 10, 2020
July 1, 2020
18.9 years
July 31, 2007
July 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Outcome of Children Exposed to Chemotherapy While in Their Mother's Womb
Health assessments performed until child reaches the age of 18.
Study Arms (1)
Multimodality Treatment
EXPERIMENTALMultimodality (chemotherapy, surgery and radiation therapy) treatment: 5-Fluorouracil + Doxorubicin + Cyclophosphamide (FAC)
Interventions
500 mg/m\^2 By Vein Daily x 2 Days
500 mg/m\^2 By Vein On Day 1
50 mg/m\^2 By Vein Over 72 Hours
Eligibility Criteria
You may qualify if:
- · All patients with primary breast cancer occurring during pregnancy will be eligible for enrollment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 25547133DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Litton, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2007
First Posted
August 2, 2007
Study Start
August 7, 2001
Primary Completion
July 8, 2020
Study Completion
July 8, 2020
Last Updated
July 10, 2020
Record last verified: 2020-07