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CompletedNCT00493870Updated Mar 2, 2023Results posted

TAC Versus TC for Adjuvant Breast Cancer

A Phase 3 interventional study of Docetaxel and Doxorubicin in Breast Cancer, sponsored by US Oncology Research. Completed at 95 sites in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by US Oncology Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,961
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 1,961 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

US Oncology Research is the lead sponsor of 29 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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.

  • 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

Exclusion criteria

Exclusion Criteria:

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
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,961 participants (actual)

Study arms

  • Experimental
    TC

    docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2

    Drug: Docetaxel · Drug: Cyclophosphamide

  • Active comparator
    TAC

    doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2 and docetaxel 75 mg/m2

    Drug: Docetaxel · Drug: Doxorubicin · Drug: Cyclophosphamide

Interventions

  • DrugDocetaxel

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

    Also known as: Taxotere

  • DrugDoxorubicin

    • 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).

    Also known as: Adriamycin

  • DrugCyclophosphamide

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

    Also known as: Cytoxan

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 3 years from randomization into study

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 3 years from randomization into study

07

Results

Posted Mar 2, 2023

Participant flow

Participant flow — Overall Study
MilestoneTC ArmTAC Arm
Started981980
Completed969965
Not completed1215
Withdrew: Lost to follow-up1215

Outcome measures

Primary3-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.

Time frame:
3 years from randomization into study
Reported as:
Number · percentage of participants
3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients
percentage of participantsTC ArmTAC Arm
3-year Invasive Disease-free Survival (IDFS) Among Analyzed ITT Patients91.1 (89.1 to 92.8)93.2 (91.3 to 94.6)
Statistical analysis
  • TC Arm vs TAC Arm · Log Rank · p = 0.05
Primary3-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.

Time frame:
3 years from randomization into study
Reported as:
Number · percentage of participants
3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients
percentage of participantsTC ArmTAC Arm
3-year Invasive Disease-free Survival (IDFS) Among Per-protocol Patients91.3 (89.3 to 93.0)93.2 (91.3 to 94.7)
Secondary3-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.

Time frame:
3 years from randomization into study
Reported as:
Number · percentage of participants
3-year DFS-DCIS, OS and RFI Among Analyzed ITT Patients
percentage of participantsTC ArmTAC Arm
3-year DFS-DCIS90.9 (88.8 to 92.6)93.0 (91.1 to 94.5)
3-year OS96.8 (95.4 to 97.7)96.8 (95.5 to 97.8)
3-year RFI91.9 (90.0 to 93.5)94.5 (92.8 to 95.9)
Secondary3-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.

Time frame:
3 years from randomization into study
Reported as:
Number · percentage of participants
3-year DFS-DCIS, OS and RFI Among Per-protocol Patients.
percentage of participantsTC ArmTAC Arm
3-year DFS-DCIS91.1 (89.0 to 92.8)93.0 (91.1 to 94.5)
3-year OS96.8 (95.5 to 97.8)96.8 (95.4 to 97.8)
3-year RFI92.1 (90.2 to 93.7)94.5 (92.8 to 95.8)
SecondaryNumber 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

Time frame:
10 years (from baseline to end of study participation)
Reported as:
Count of participants · Participants
Number and Frequency of Participants by TOP2A Status by Study Treatment
ParticipantsTC ArmTAC Arm
Amplification1414
Deletion131128
Normal479489
Secondary3-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.

Time frame:
3 years from randomization into study
Reported as:
Number · percentage of participants
3-year DFS Stratified by TOP2A Among TC Arm
percentage of participantsAmplificationDeletionNormal
3-year DFS Stratified by TOP2A Among TC Arm85.1 (52.3 to 96.1)82.8 (75.1 to 88.3)93.8 (91.2 to 95.6)
Secondary3-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.

Time frame:
3 years from randomization into study
Reported as:
Number · percentage of participants
3-year DFS Stratified by TOP2A Among TAC Arm
percentage of participantsAmplificationDeletionNormal
3-year DFS Stratified by TOP2A Among TAC Arm100 (100 to 100)90.9 (84.2 to 94.9)93.2 (90.6 to 95.2)

Adverse events

Collected over From Baseline to 30 days after last dose of study treatment, approximately 22 weeks. All-Cause Mortality was from baseline to end of study participation, approximately 10 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TC Arm110/969 (11.4%)264/969 (27.2%)680/969 (70.2%)
TAC Arm88/965 (9.1%)330/965 (34.2%)746/965 (77.3%)
Most frequent serious events
Showing 10 of 141
Most frequent serious events
EventTC ArmTAC Arm
FEBRILE NEUTROPENIAInfections and infestations42/96944/965
FEVERInfections and infestations21/96913/965
NEUTROPHIL COUNTBlood and lymphatic system disorders10/96918/965
DEHYDRATIONGastrointestinal disorders11/96918/965
VOMITINGGastrointestinal disorders8/96914/965
DIARRHEAGastrointestinal disorders11/96912/965
NAUSEAGastrointestinal disorders7/96910/965
INFECTION - OTHER (SPECIFY)Infections and infestations9/96910/965
ABDOMINAL PAINInvestigations7/96910/965
THROMBOSISVascular disorders1/9699/965
Most frequent other events
Showing 10 of 40
Most frequent other events
EventTC ArmTAC Arm
ALOPECIASkin and subcutaneous tissue disorders543/969538/965
FATIGUEGeneral disorders470/969498/965
NAUSEAGastrointestinal disorders326/969413/965
DIARRHEAGastrointestinal disorders251/969331/965
NEUTROPENIABlood and lymphatic system disorders294/969243/965
NEUROPATHYNervous system disorders203/969171/965
EDEMABlood and lymphatic system disorders188/969142/965
PAINInvestigations185/969139/965
ANEMIABlood and lymphatic system disorders164/969183/965
CONSTIPATIONGastrointestinal disorders153/969175/965

Baseline characteristics

Age, Continuous
Age, Continuous(years)TC ArmTAC ArmTotal
Mean53.4 ± 9.253.1 ± 8.953.3 ± 9.1
Sex: Female, Male
Sex: Female, Male(Participants)TC ArmTAC ArmTotal
Female9699651934
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)TC ArmTAC ArmTotal
Caucasian7187411459
Hispanic14197238
Black9495189
Asian112233
Indian123
Hawaiian022
Other257
Unknown213
Baseline Performance Status (ECOG)
Baseline Performance Status (ECOG)(Participants)TC ArmTAC ArmTotal
ECOG 08608571717
ECOG 1109108217
Stage
Stage(Participants)TC ArmTAC ArmTotal
I136124260
II7057161421
III128125253
Hormone Receptor Status
Hormone Receptor Status(Participants)TC ArmTAC ArmTotal
Positive6796781357
Negative290287577
Histology
Histology(Participants)TC ArmTAC ArmTotal
Ductal8117891600
Lobular87100187
Mixed242650
Other474895
Unknown022
Tumor size
Tumor size(cm)TC ArmTAC ArmTotal
Mean2.7 ± 1.52.6 ± 1.52.6 ± 1.5

3 further baseline measures are reported on the registry.

08

Study locations

95 sites
  • Birmingham Hematology and Oncology
    Birmingham, Alabama 35205, United States
  • Hematology Oncology Associates
    Phoenix, Arizona 85012, United States
  • Northern AZ Hematology Oncology Associates-AOA
    Sedona, Arizona 86336, United States
  • Arizona Oncology Associates DBA HOPE
    Tucson, Arizona 85704, United States
  • Central Hematology Oncology Medical Group, Inc.
    Alhambra, California 91801, United States
  • Comprehensive Blood and Cancer Center
    Bakersfield, California 93309, United States
  • St. Jude Hertiage Medical Group
    Fullerton, California 92835, United States
  • Wilshire Oncology Medical Group
    La Verne, California 91750, United States
  • Antelope Valley Cancer Center
    Lancaster, California 93534, United States
  • Pacific Shores Medical Group
    Long Beach, California 90813, United States
  • University of California-Los Angeles
    Los Angeles, California 90095, United States
  • North Valley Hematology/Oncology Medical Group
    Northridge, California 91325, United States
  • Ventura County Hematology-Oncology Specialist
    Oxnard, California 93030, United States
  • SAMSUM Clinic
    Santa Barbara, California 93105, United States
  • Santa Barabra Hematology Oncology Medical Group, Inc.
    Santa Barbara, California 93105, United States
  • Central Coast Medical Oncology Corporation
    Santa Maria, California 93454, United States
  • Rocky Mountain Cancer Center-Rose
    Denver, Colorado 80220, United States
  • Flordia Cancer Specialist
    Fort Myers, Florida 33916, United States
  • Melbourne Internal Medicine Associates
    Melbourne, Florida 32901, United States
  • Advanced Medical Specialist
    Miami, Florida 33176, United States
  • Florida Cancer Institute
    New Port Richey, Florida 34655, United States
  • Ocala Oncology Center
    Ocala, Florida 34474, United States
  • Cancer Centers of Florida, P.A.
    Ocoee, Florida 34761, United States
  • Suburban Hematology-Oncology Associates, PC
    Lawrenceville, Georgia 30045, United States
  • Northwest Georgia Oncology Centers, PC
    Marietta, Georgia 30060, United States
  • Hematology Oncology Associates of IL
    Chicago, Illinois 60611, United States
  • Cancer Care & Hematology Specialists of Chicagoland
    Niles, Illinois 60714, United States
  • Central Indiana Cancer Centers
    Indianapolis, Indiana 46627, United States
  • Hope Center
    Terre Haute, Indiana 47802, United States
  • Kansas City Cancer Centers-Southwest
    Overland Park, Kansas 66210, United States
  • Maryland Oncology Hematology, P.A.
    Columbia, Maryland 21044, United States
  • Alliance Hematology Oncology PA
    Westminster, Maryland 21157, United States
  • Minnesota Oncology Hematology, P.A.
    Minneapolis, Minnesota 554404, United States
  • Missouri Cancer Associates
    Columbia, Missouri 65201, United States
  • Arch Medical Services, Inc.
    Saint Louis, Missouri 63141, United States
  • Comprehensive Cancer Center of Nevada
    Henderson, Nevada 89052, United States
  • Hematology-Oncology Associates of NNJ, P.A.
    Morristown, New Jersey 07960, United States
  • Southern New Mexico Cancer Center
    Las Cruces, New Mexico 88011, United States
  • New Mexico Cancer Care Associates
    Santa Fe, New Mexico 87505, United States
  • New York Oncology Hematology, P.C.
    Albany, New York 12206, United States
  • Interlakes Oncology Hematology, PC
    Rochester, New York 14623, United States
  • Cancer Centers of North Carolina
    Raleigh, North Carolina 27607, United States
  • Mahoning Valley Hematology Oncology Associates
    Boardman, Ohio 44514, United States
  • Oncology Hematology Care, Inc.
    Cincinnati, Ohio 45242, United States
  • Greater Dayton Cancer Center
    Kettering, Ohio 45409, United States
  • Willamette Valley Cancer Center
    Eugene, Oregon 97401, United States
  • Medical Oncology Associates
    Kingston, Pennsylvania 18704, United States
  • Rittenhouse Hematology/Oncology
    Philadelphia, Pennsylvania 19107, United States
  • Cancer Centers of the Carolinas
    Greenville, South Carolina 29615, United States
  • Chattanooga Oncology & Hematology Associates, PC
    Chattanooga, Tennessee 37404, United States
  • The Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • Texas Cancer Center-Abilene (South)
    Abilene, Texas 79606, United States
  • Texas Oncology, P.A.-Amarillo
    Amarillo, Texas 79106, United States
  • Texas Cancer Center
    Arlington, Texas 76014, United States
  • Texas Oncology Cancer Center
    Austin, Texas 78731, United States
  • Mamie McFaddin Ward Cancer Center
    Beaumont, Texas 77702, United States
  • Texas Oncology -Bedford
    Bedford, Texas 76022, United States
  • Texas Cancer Center at Medical City
    Dallas, Texas 75230, United States
  • Texas Oncology
    Dallas, Texas 75231, United States
  • Methodist Charlton Cancer Ctr.
    Dallas, Texas 75237, United States
  • Texas Oncology
    Dallas, Texas 75246, United States
  • Texas Cancer Center
    Denton, Texas 76210, United States
  • El Paso Cancer Treatment Ctr
    El Paso, Texas 79915, United States
  • Texas Oncology
    Fort Worth, Texas 76104, United States
  • Texas Oncology
    Garland, Texas 75042, United States
  • Texas Oncology, P.A.
    Houston, Texas 77024, United States
  • Lake Vista Cancer Center
    Lewisville, Texas 75067, United States
  • Longview Cancer Center
    Longview, Texas 75601, United States
  • South Texas Cancer Center-McAllen
    McAllen, Texas 78503, United States
  • Texas Cancer Center of Mesquite
    Mesquite, Texas 75150, United States
  • Allison Cancer Center
    Midland, Texas 79701, United States
  • Texas Oncology-Odessa
    Odessa, Texas 79761, United States
  • Paris Regional Cancer Center
    Paris, Texas 75460, United States
  • South Texas Oncology and Hematology, P.A.
    San Antonio, Texas 78207, United States
  • San Antonio Tumor and Blood Clinic
    San Antonio, Texas 78217, United States
  • HOAST-Medical Dr.
    San Antonio, Texas 78229, United States
  • Texas Cancer Center-Sherman
    Sherman, Texas 75090, United States
  • Texas Oncology Cancer Center-Sugar Land
    Sugar Land, Texas 77479, United States
  • Tyler Cancer Center
    Tyler, Texas 75702, United States
  • Texas Oncology Cancer Care and Research
    Waco, Texas 76712, United States
  • Texas Oncology PA
    Webster, Texas 77598, United States
  • Texoma Cancer Center
    Wichita Falls, Texas 76310, United States
  • Fairfax Northern VA Hem-Onc PC
    Fairfax, Virginia 22031, United States
  • Virginia Oncology Associates
    Norfolk, Virginia 23502, United States
  • Virginia Cancer Institute
    Richmond, Virginia 23230, United States
  • Onc and Hem Associates os SW VA, Inc.
    Salem, Virginia 24153, United States
  • Highline Medical Oncology
    Burien, Washington 98166, United States
  • Pudget Sound Cancer Center-Edmonds
    Edmonds, Washington 98026, United States
  • Columbia Basin Hematology and Oncology
    Kennewick, Washington 99336, United States
  • Puget Sound Cancer Center-Seattle
    Seattle, Washington 98133, United States
  • Cancer Care Northwest-South
    Spokane, Washington 99202, United States
  • Northwest Cancer Specialists-Vancouver
    Vancouver, Washington 98684, United States
  • Yakima Valley Mem Hosp/North Star Lodge
    Yakima, Washington 98902, United States
  • Yakima Valley Memorial Hospital/North Star Lodge
    Yakima, Washington 98902, United States
  • Raleigh Regional Cancer Center
    Beckley, West Virginia 25801, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00493870
Lead sponsor
US Oncology Research
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Jun 28, 2007
Start date
May 29, 2007
Primary completion
May 31, 2015
Completion
Mar 30, 2020
Results posted
Mar 2, 2023
Last update
Mar 2, 2023

Study contacts

Joanne L Blum, MD
principal investigator · US Oncology Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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