Clinical trial · Interventional
Primary Breast Cancer Occurring Concomitant With Pregnancy
Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy
NCT00510367CI-TRIAL-00045903completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pregnancy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multimodality Treatment
- description
- Multimodality (chemotherapy, surgery and radiation therapy) treatment: 5-Fluorouracil + Doxorubicin + Cyclophosphamide (FAC)
- interventionNames
- Drug: 5-Fluorouracil
- Drug: Cyclophosphamide
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Response of Multimodality (Chemotherapy, Surgery and Radiation Therapy) Treatment of Primary Breast Cancer in Pregnant Participants
- timeFrame
- 4 months
- description
- Ultrasound obtained after four cycles of neoadjuvant chemotherapy to assess response.
Secondary outcomes (1)
- measure
- Outcome of Children Exposed to Chemotherapy While in Their Mother's Womb
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMurthy 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 25547133