AzTrials
AzTrials

Breast CancerPhase 3NCT00493870

TAC Versus TC for Adjuvant Breast Cancer

A Phase 3 study testing Docetaxel, Doxorubicin and Cyclophosphamide in people with Breast Cancer, run by US Oncology Research at 95 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Docetaxel, Doxorubicin and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,961 participants
Where
95 sitesUnited States
Study dates
29 May 2007to 30 Mar 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A woman will be eligible for inclusion in this study if she meets all of the following criteria:
  • Age >18 to <70 years old.
  • Has known ER and PR status
  • Has HER2 nonamplified disease, confirmed by FISH
  • Has known menopausal status (see Section 7.3 for criteria)
  • Has operable, histologically confirmed, Stage I, IIA, IIB, or IIIA, IIIB, or IIIC invasive carcinoma of the breast. Bilateral synchronous breast cancer is allowable provided that 1 primary meets the inclusion criteria.
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  • Meets 1 of the 3 following criteria:
  • T1-3N1-3M0 if ER positive or negative
  • T2-3N0M0 if ER positive or negative
  • T1N0M0 if ER and PR negative
  • Has complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS)
  • Has had no prior chemotherapy unless >5 years ago
  • Has an ECOG Performance Status (PS) 0-1
  • Has laboratory values of: See protocol for specific details
  • Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details
  • Has normal cardiac function as evidenced by a LVEF >50%, but WNL by institutional standard by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same modality must be used consistently throughout the study to evaluate LVEF. Ejection fraction as determined by ECHO must be WNL by institutional standard.
  • Has no evidence of metastatic disease outside of breast by physical examination and chest x-ray. Other scans if done as needed by the patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease
  • Has had baseline bilateral mammography
  • It has been <84 days since the date of definitive surgery (eg, mastectomy or, in the case of a breast-sparing procedure, axillary dissection) with adequate wound healing, as determined by the Treating Physician
  • Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause])
  • If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive only) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
  • Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VI).
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form

Who cannot join

  • A woman will be excluded from this study if she meets any of the following criteria:
  • Has any evidence of metastatic disease following surgical resection of the primary tumor including: positive surgical margins, staging work-up, or physical examination suspicious for malignant disease
  • Has T4 disease (ie, patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes)
  • Has Stage IV breast cancer (M1 disease on TNM staging system)
  • Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  • Has had neoadjuvant chemotherapy for this breast cancer
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  • Has ever had a myocardial infarction (MI) or has a history of heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes
  • Is receiving concurrent immunotherapy, hormonal therapy (eg, tamoxifen, hormone replacement therapy), or radiation therapy. Must discontinue prior to registering on the study.
  • Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days
  • Has peripheral neuropathy >Grade 1
  • Has had a major organ allograft or condition requiring chronic immunosuppression (ie, kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who have received corneal transplants or cadaver skin or bone transplants are eligible.
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
  • Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix, DCIS, which could affect the diagnosis or assessment of any of the study drugs
  • In an obese patient to whom the Treating Physician would not be comfortable administering full doses of study drugs as calculated by the BSA. Obese patients will be treated based on actual body weight. Obese patients treated with full doses based on actual BSA are eligible.
  • Is pregnant or breastfeeding
  • Is deemed unable to comply with requirements of study

Trial locations and contacts

95 sites in 1 country.

95 sites in 1 country

United States95 sites

  • Texas Cancer Center-Abilene (South)

    Abilene, Texas, 79606

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Central Hematology Oncology Medical Group, Inc.

    Alhambra, California, 91801

  • Texas Oncology, P.A.-Amarillo

    Amarillo, Texas, 79106

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Raleigh Regional Cancer Center

    Beckley, West Virginia, 25801

  • Texas Oncology -Bedford

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35205

  • Mahoning Valley Hematology Oncology Associates

    Boardman, Ohio, 44514

  • Highline Medical Oncology

    Burien, Washington, 98166

  • Chattanooga Oncology & Hematology Associates, PC

    Chattanooga, Tennessee, 37404

  • Hematology Oncology Associates of IL

    Chicago, Illinois, 60611

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology

    Dallas, Texas, 75231

  • Methodist Charlton Cancer Ctr.

    Dallas, Texas, 75237

  • Texas Oncology

    Dallas, Texas, 75246

  • Texas Cancer Center

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center-Rose

    Denver, Colorado, 80220

  • Pudget Sound Cancer Center-Edmonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Ctr

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Fairfax Northern VA Hem-Onc PC

    Fairfax, Virginia, 22031

  • Flordia Cancer Specialist

    Fort Myers, Florida, 33916

  • Texas Oncology

    Fort Worth, Texas, 76104

  • St. Jude Hertiage Medical Group

    Fullerton, California, 92835

  • Texas Oncology

    Garland, Texas, 75042

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29615

  • Comprehensive Cancer Center of Nevada

    Henderson, Nevada, 89052

  • Texas Oncology, P.A.

    Houston, Texas, 77024

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46627

  • Columbia Basin Hematology and Oncology

    Kennewick, Washington, 99336

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Wilshire Oncology Medical Group

    La Verne, California, 91750

  • Antelope Valley Cancer Center

    Lancaster, California, 93534

  • Southern New Mexico Cancer Center

    Las Cruces, New Mexico, 88011

  • Suburban Hematology-Oncology Associates, PC

    Lawrenceville, Georgia, 30045

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Longview Cancer Center

    Longview, Texas, 75601

  • University of California-Los Angeles

    Los Angeles, California, 90095

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • South Texas Cancer Center-McAllen

    McAllen, Texas, 78503

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Advanced Medical Specialist

    Miami, Florida, 33176

  • Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 554404

  • Hematology-Oncology Associates of NNJ, P.A.

    Morristown, New Jersey, 07960

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • North Valley Hematology/Oncology Medical Group

    Northridge, California, 91325

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • Texas Oncology-Odessa

    Odessa, Texas, 79761

  • Kansas City Cancer Centers-Southwest

    Overland Park, Kansas, 66210

  • Ventura County Hematology-Oncology Specialist

    Oxnard, California, 93030

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Rittenhouse Hematology/Oncology

    Philadelphia, Pennsylvania, 19107

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Interlakes Oncology Hematology, PC

    Rochester, New York, 14623

  • Onc and Hem Associates os SW VA, Inc.

    Salem, Virginia, 24153

  • South Texas Oncology and Hematology, P.A.

    San Antonio, Texas, 78207

  • San Antonio Tumor and Blood Clinic

    San Antonio, Texas, 78217

  • HOAST-Medical Dr.

    San Antonio, Texas, 78229

  • SAMSUM Clinic

    Santa Barbara, California, 93105

  • Santa Barabra Hematology Oncology Medical Group, Inc.

    Santa Barbara, California, 93105

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • Puget Sound Cancer Center-Seattle

    Seattle, Washington, 98133

  • Northern AZ Hematology Oncology Associates-AOA

    Sedona, Arizona, 86336

  • Texas Cancer Center-Sherman

    Sherman, Texas, 75090

  • Cancer Care Northwest-South

    Spokane, Washington, 99202

  • Arch Medical Services, Inc.

    St Louis, Missouri, 63141

  • Texas Oncology Cancer Center-Sugar Land

    Sugar Land, Texas, 77479

  • Hope Center

    Terre Haute, Indiana, 47802

  • Arizona Oncology Associates DBA HOPE

    Tucson, Arizona, 85704

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists-Vancouver

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care and Research

    Waco, Texas, 76712

  • Texas Oncology PA

    Webster, Texas, 77598

  • Alliance Hematology Oncology PA

    Westminster, Maryland, 21157

  • Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Yakima Valley Mem Hosp/North Star Lodge

    Yakima, Washington, 98902

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients

The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer.

Read the detailed description

Both TAC (docetaxel, doxorubicin, and cyclophosphamide) and TC (docetaxel and cyclophosphamide) are established adjuvant chemotherapy regimens for early stage breast cancer. TAC, however, due to the inclusion of the anthracycline doxorubicin, carries a high risk of hematologic and cardiotoxic adverse effects. Substantial evidence supports the concept that early stage HER2-negative breast cancers will benefit similarly from anthracycline-based adjuvant and non-anthracycline-based chemotherapy.

Further, approximately 0 to 9% of HER2-negative breast cancers have alterations in the TOP2A gene, which may predict for benefit from anthracycline-based chemotherapy.

We hypothesize that 6 cycles of TC versus 6 cycles of TAC will have similar efficacy in the treatment of early stage HER2-negative breast cancer and that TC will have less toxicity. If this hypothesis were upheld and the anthracycline doxorubicin could be eliminated from the regimen while obtaining similar efficacy in this population of patients, it would not only be an important advance in the understanding of the biology of cancer, but it would also be of significant clinical benefit to women with breast cancer.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide

  • DoxorubicinDrug

    Also called Adriamycin

    • Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrastim 6 mg SC on Day 2 (or filgrastim 5 mcg/kg SC per standard of care).

  • CyclophosphamideDrug

    Also called Cytoxan

    600 mg/m2 IV over 15-30 minutes on Day 1.

Study groups in NCT00493870
Study groupRoleWhat they receive
TCExperimentaldocetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2
Receives: Drug: Docetaxel; Drug: Cyclophosphamide
TACActive comparatordoxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2 and docetaxel 75 mg/m2
Receives: Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients

    The primary objective of the study is to compare the 3-year invasive disease-free survival (IDFS) of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer among analyzed ITT patients. ITT patients are all patients who were randomized, whether or not they followed protocol. IDFS, defined as the time from the date of randomization to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Patients who have not had any such event at the time of data analysis will be censored at the last date they were known to be event-free.

    Measured: 3 years from randomization into study

  2. 3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients

    The primary objective of the study is to compare the 3-year invasive disease-free survival (IDFS) of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer among per-protocol patients. Per-protocol only includes those patients who were randomized and received treatment as outlined in the protocol.

    Measured: 3 years from randomization into study

Secondary outcomes (5)

  1. 3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients

    To compare disease-free survival-ductal carcinoma in situ (DFS-DCIS),overall survival (OS) and recurrence free interval (RFI) of TC with TAC. DFS-DCIS, defined as the time from the date of randomization to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or non-invasive), regional recurrence, distant recurrence, contralateral breast cancer (invasive or non-invasive), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Patients who have not had any such event at the time of data analysis will be censored at the last date they were known to be event-free.

    Measured: 3 years from randomization into study

  2. 3-year DFS-DCIS, OS and RFI Among Per-protocol Patients.

    To compare disease-free survival-ductal carcinoma in situ (DFS-DCIS),overall survival (OS) and recurrence free interval (RFI) of TC with TAC among per protocol patients.

    Measured: 3 years from randomization into study

  3. Number and Frequency of Participants by TOP2A Status by Study Treatment

    To evaluate the effectiveness of TC and TAC in TOP2A altered (amplified, deleted, or overexpressed at the protein level) early stage HER2-negative breast cancer

    Measured: 10 years (from baseline to end of study participation)

  4. 3-year DFS Stratified by TOP2A Among TC Arm

    To evaluate DFS among TC in TOP2A altered (amplified, deleted, or overexpressed at the protein level) early stage HER2-negative breast cancer.

    Measured: 3 years from randomization into study

  5. 3-year DFS Stratified by TOP2A Among TAC Arm

    To evaluate DFS among TAC in TOP2A altered (amplified, deleted, or overexpressed at the protein level) early stage HER2-negative breast cancer.

    Measured: 3 years from randomization into study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2007 (estimated)
  2. Study start29 May 2007
  3. Primary completion31 May 2015
  4. Study completion30 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,961 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493870
Sponsor's protocol ID
06090
Other IDs
11271
Status last verified
Feb 2023
First submitted
27 Jun 2007
Last updated
2 Mar 2023
Data monitoring committee
No

Publications

  • Geyer CE Jr, Blum JL, Yothers G, Asmar L, Flynn PJ, Robert NJ, Hopkins JO, O'Shaughnessy JA, Rastogi P, Puhalla SL, Hilton CJ, Dang CT, Gomez HL, Vukelja SJ, Lyss AP, Paul D, Brufsky AM, Colangelo LH, Swain SM, Mamounas EP, Wolmark N. Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]). J Clin Oncol. 2024 Apr 20;42(12):1344-1349. doi: 10.1200/JCO.23.01428. Epub 2024 Feb 9.

    PubMed 38335467

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Doxorubicin and Cyclophosphamide in people with Breast Cancer, run by US Oncology Research at 95 sites 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 24 inclusion and 17 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients (time frame: 3 years from randomization into study). The study lists 2 primary outcomes in all. 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 NCT00493870, 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 2 Mar 2023.

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