Breast CancerEarly Phase 1NCT00510367
Primary Breast Cancer Occurring Concomitant With Pregnancy
A Early Phase 1 study testing 5-Fluorouracil, Cyclophosphamide and Doxorubicin in people with Breast Cancer and Pregnancy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Pregnancy
- What is being tested?
- 5-Fluorouracil, Cyclophosphamide and Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2001to 8 Jul 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with primary breast cancer occurring during pregnancy will be eligible for enrollment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Pregnancy
- Being tested
- 5-Fluorouracil, Cyclophosphamide, Doxorubicin
- Keywords
- Breast Cancer, FAC, Doxorubicin, Adriamycin, Rubex, 5-Fluorouracil, 5-FU, Adrucil, Efudex, Cyclophosphamide, Cytoxan, Neosar, Pregnancy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluorouracilDrug
Also called 5-FU, Adrucil, Efudex
500 mg/m^2 By Vein Daily x 2 Days
CyclophosphamideDrug
Also called Cytoxan, Neosar
500 mg/m^2 By Vein On Day 1
DoxorubicinDrug
Also called AD, Hydroxydaunomycin hydrochloride, Adriamycin, Rubex
50 mg/m^2 By Vein Over 72 Hours
| Study group | Role | What they receive |
|---|---|---|
| Multimodality Treatment | Experimental | Multimodality (chemotherapy, surgery and radiation therapy) treatment:
5-Fluorouracil + Doxorubicin + Cyclophosphamide (FAC) Receives: Drug: 5-Fluorouracil; Drug: Cyclophosphamide; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
Outcome of Children Exposed to Chemotherapy While in Their Mother's Womb
Health outcomes of children exposed to chemotherapy in utero documented by survey.
Measured: Health assessments performed until child reaches the age of 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study start7 Aug 2001
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Litton, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510367
- Sponsor's protocol ID
- ID01-193
- Other IDs
- NCI-2012-01578
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2007
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 25547133
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy
- ClinicalTrials.gov ID
- NCT00510367
- Acronym / sponsor ID
- ID01-193
- Conditions
- Breast Cancer, Pregnancy
- Keywords
- Breast Cancer, FAC, Doxorubicin, Adriamycin, Rubex, 5-Fluorouracil, 5-FU, Adrucil
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 7 Aug 2001 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodality Treatment | Experimental | Drug: 5-Fluorouracil, Drug: Cyclophosphamide, Drug: DoxorubicinMultimodality (chemotherapy, surgery and radiation therapy) treatment: 5-Fluorouracil + Doxorubicin + Cyclophosphamide (FAC) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with primary breast cancer occurring during pregnancy will be eligible for enrollment.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-FluorouracilAlso: 5-FU, Adrucil, Efudex500 mg/m^2 By Vein Daily x 2 Days | Drug | Multimodality Treatment |
| CyclophosphamideAlso: Cytoxan, Neosar500 mg/m^2 By Vein On Day 1 | Drug | Multimodality Treatment |
| DoxorubicinAlso: AD, Hydroxydaunomycin hydrochloride, Adriamycin, Rubex50 mg/m^2 By Vein Over 72 Hours | Drug | Multimodality Treatment |
Primary outcome
Response of Multimodality (Chemotherapy, Surgery and Radiation Therapy) Treatment of Primary Breast Cancer in Pregnant Participants
Time frame: 4 months
Ultrasound obtained after four cycles of neoadjuvant chemotherapy to assess response.
1 secondary outcome
Outcome of Children Exposed to Chemotherapy While in Their Mother's Womb
Time frame: Health assessments performed until child reaches the age of 18.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Derived from this study: PubMed 25547133Murthy 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.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Litton, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 5-Fluorouracil, Cyclophosphamide and Doxorubicin in people with Breast Cancer and Pregnancy, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of Multimodality (Chemotherapy, Surgery and Radiation Therapy) Treatment of Primary Breast Cancer in Pregnant Participants (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.