Molecular Triaging of Newly Diagnosed Breast Cancer

2014-08-27 03:12:19 | BioPortfolio


The goal of this clinical research study is to learn if using "gene signatures" can be an effective way to decide the best treatment for breast cancer patients. Gene signatures may be able to help researchers predict who will respond to chemotherapy given before surgery.


At this time, treatment of stage I-III breast cancer for patients who are at high risk for the cancer returning is surgery and chemotherapy. If the cancer is positive for estrogen hormone receptor, patients also have endocrine therapy.

The most common standard chemotherapy treatment regimens for breast cancer at M. D. Anderson are paclitaxel (T), followed by treatments with fluorouracil (F), doxorubicin (A) or epirubicin (E), and cyclophosphamide (C). These chemotherapy combinations are known as T/FAC and T/FEC. However, not all patients respond to these treatments, so researchers at M. D. Anderson have developed tests to predict how much a person's breast cancer might respond to T/FAC or T/FEC chemotherapy.

Fine needle aspiration (FNA) of the tumor are collected after numbing the skin of the breast with local anesthesia, and the genes within the FNA sample are measured to calculate the results of treatment prediction tests before treatment is selected.

In this research study, the gene-based tests will help to select treatment based on the predictions of response to chemotherapy, and to then measure the tumor response from the surgery after the treatment.

Study Drugs T/FAC and T/FEC are designed to damage the DNA (genetic material of cells), which may cause cancer cells to die.

Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells and make them more susceptible to chemotherapy.

Tumor Biopsies If you are found eligible to take part in this study, you will have 3-4 fine needle biopsies of the tumor collected. The skin over the tumor and the breast tissues surrounding the tumor will be numbed using local anesthesia. To perform fine needle aspiration biopsies, tumor cells are withdrawn from the tumor using a very thin needle alone, or using a syringe.

These biopsies will be used to measure different genes and to predict how the cancer may respond to different treatments.

Based on the information from these gene measurements, a computer model will predict if the cancer is highly sensitive to chemotherapy and is likely to shrink to a great extent or disappear completely due to chemotherapy. This response prediction is done separately for estrogen receptor-positive and estrogen receptor-negative cancers.

Study Groups:

If the biopsies show that the cancer may respond well to standard T/FAC or T/FEC chemotherapy, you will receive the chemotherapy before surgery (Group 1).

If the biopsies show that the cancer may not respond as well to standard T/FAC or T/FEC chemotherapy, you will be randomly assigned (as in the roll of dice) to 1 of 2 groups.

- If you are in Group 2, you will receive T/FAC or T/FEC chemotherapy before surgery. One (1) out of 3 participants whose cancer may not respond as well will be assigned to this group.

- If you are in Group 3, you will receive T/FAC or T/FEC chemotherapy combined with bevacizumab before surgery. Two (2) out of 3 participants whose cancer may not respond as well will be assigned to this group.

Your doctor will decide if you receive T/FAC or T/FEC.

Study Drug Administration:

Groups 1 and 2:

Once a week during Weeks 1-12, you will receive paclitaxel by vein over about 1-2 hours.

Once every 3 weeks during Weeks 13-24, you will receive T/FAC or T/FEC by vein over about 3-4 hours. This chemotherapy treatment is considered routine standard of care and you may receive this treatment closer to home outside of M. D. Anderson.

After all chemotherapy, you will have surgery at M. D. Anderson to remove the cancer.

Group 3:

Once a week during Weeks 1-12, you will receive paclitaxel by vein over about 1-2 hours.

Once every 2 weeks during Weeks 1-18, you will receive bevacizumab by vein once over about 1-2 hours. If your doctor thinks is it necessary, and based on heart related test results, you may only receive bevacizumab during Weeks 1-12.

Once every 3 weeks during Weeks 13-24, you will receive T/FAC or T/FEC by vein over about 4 hours. You must receive your chemotherapy at M. D. Anderson if you are in this group.

After all chemotherapy, you will have surgery at M. D. Anderson to remove the cancer.

Study Visits:

All participants will have routine visits at M. D. Anderson at least once every 12 weeks during chemotherapy. Your doctor will determine the tests and procedures to be performed.

If you are assigned to Group 3, you will also have the following additional procedures.

- You will have a urine analysis within 1 month after starting therapy.

- You will have an echocardiogram to check your heart's health within 3 months after you begin treatment.

Length of Study:

You may receive chemotherapy for up to 6 months. Once surgery is performed, your participation in this study is complete. Your doctor will decide together with you what further treatment you will need after surgery.


For as long as possible, researchers will follow your health by reviewing your medical records after you have completed this study.

This is an investigational study. The biopsy and testing to predict response to chemotherapy is not FDA approved or commercially available. Its use in this study is investigational. The chemotherapy and surgery are standard of care for patients with breast cancer. The addition of bevacizumab to treatment is also investigational.

Up to 303 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Breast Cancer


Paclitaxel, Fluorouracil, Doxorubicin, Epirubicin, Cyclophosphamide, Bevacizumab


UTMD Anderson Cancer Center
United States


Not yet recruiting


M.D. Anderson Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:12:19-0400

Clinical Trials [8166 Associated Clinical Trials listed on BioPortfolio]

Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer

This is an open -label randomized phase II study of dose-dense Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2 (FEC75) and Epirubicin 90mg/m2 (FEC90)...

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin ...

Cyclophosphamide, Methotrexate, and Fluorouracil, With or Without Epirubicin Hydrochloride, in Treating Women Who Have Undergone Surgery for Breast Cancer (Group III Closed to New Patients as of 12/7/2009)

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, fluorouracil, and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells, either ...

Preoperative Dose-dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab in Operable Breast Cancer

Dose dense chemotherapy, which is the term for Adriamycin and Cyclophosphamide (AC) followed by Taxol chemotherapy given every two weeks, is the standard chemotherapy for the treatment of ...

Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Ra...

PubMed Articles [14622 Associated PubMed Articles listed on BioPortfolio]

Effectiveness and tolerability of neoadjuvant pertuzumab-containing regimens for HER2-positive localized breast cancer.

Based on improvement in pathologic complete response (pCR) in the NeoSphere and TRYPHAENA studies, the FDA approved neoadjuvant pertuzumab for HER2+ localized breast cancer. These studies demonstrat...

Correlation of circulating pro-angiogenic miRNAs with cardiotoxicity induced by epirubicin/cyclophosphamide followed by docetaxel in patients with breast cancer.

This study aimed to evaluate predictive value of 14 pro-angiogenic miRNAs for cardiotoxicity induced by epirubicin/cyclophosphamide follow by docetaxel (EC-D) in breast cancer (BC) patients.

Double-Blind Phase III Trial of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer (E5103).

Purpose Bevacizumab improves progression-free survival but not overall survival in patients with metastatic breast cancer. E5103 tested the effect of bevacizumab in the adjuvant setting in patients wi...

Correlation of UGT2B7 Polymorphism with Cardiotoxicity in Breast Cancer Patients Undergoing Epirubicin/Cyclophosphamide-Docetaxel Adjuvant Chemotherapy.

The present study aimed to investigate correlations between uridine glucuronosyltransferase 2B7 (UGT2B7) -161 single nucleotide polymorphism C to T (C>T) and the occurrence of cardiotoxicity in Chines...

Adjuvant dose-dense doxorubicin-cyclophosphamide versus docetaxel-doxorubicin-cyclophosphamide for high-risk breast cancer: First results of the randomised MATADOR trial (BOOG 2004-04).

Dose-dense administration of chemotherapy and the addition of taxanes to anthracycline-based adjuvant chemotherapy have improved breast cancer survival substantially. However, clinical trials directly...

Medical and Biotech [MESH] Definitions

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

More From BioPortfolio on "Molecular Triaging of Newly Diagnosed Breast Cancer"

Quick Search


Relevant Topics

Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Searches Linking to this Trial