Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Fluorouracil

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

Multimodality (chemotherapy, surgery and radiation therapy) treatment:

5-Fluorouracil + Doxorubicin + Cyclophosphamide (FAC)

5-Fluorouracil

Jennifer Litton, MD

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.

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.

Primary Breast Cancer Occurring Concomitant With Pregnancy

Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy

Ultrasound obtained after four cycles of neoadjuvant chemotherapy to assess response.

Health outcomes of children exposed to chemotherapy in utero documented by survey.

M.D. Anderson Cancer Center

Bone Density Conservation Agents

Tamoxifen

Exemestane

Letrozole

Anastrozole

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen

Aromatase Inhibitors (Arimidex)

Comparison of efficacy with hormonal therapy

Aromatase Inhibitors (Femara)

Aromatase Inhibitors (Aromasin)

Ramadhan Karsono, Doctoral

This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT)

This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT) between 2011 and 2016.

The primary end points are overall survival (OS) and progression free survival (PFS) with Kaplan Meier.

This study was approved by Ethical Committee in Dharmais National Cancer Hospital.

Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients

Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia

length of time from the date of pathological diagnosis until death from any cause

length of time from after treatment until tumor progression or death from any cause

Dharmais National Cancer Center Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Primary Breast Cancer Occurring Concomitant With Pregnancy	NCT00510367	Breast Cancer Pregnancy	5-Fluorouracil Cyclophosphamid... Doxorubicin	-	M.D. Anderson Cancer Center
Primary Breast Cancer Occurring Concomitant With Pregnancy	NCT00510367	Breast Cancer Pregnancy	5-Fluorouracil Cyclophosphamid... Doxorubicin	-	M.D. Anderson Cancer Center
Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients	NCT02995772	Breast Cancer	Aromatase Inhib... Tamoxifen SOB FAC Aromatase Inhib... Aromatase Inhib...	-	Dharmais National Cancer Center Hospital

Spots Global Cancer Trial Database for fac

Every month we try and update this database with for fac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fac

Every month we try and update this database with for fac cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.