ClinicalTrials.gg
CompletedNCT00193115Updated Aug 4, 2010

Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer

A Phase 2 interventional study of Docetaxel and Doxorubicin in Breast Cancer, sponsored by SCRI Development Innovations, LLC. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-04.

Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node positive and high risk breast cancer

Read the detailed description

Upon determination of eligibility, patients will receive:

Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery

Adjuvant patients will enter the study after surgery and receive Docetaxel+ Doxorubicin + Cyclophosphamide. Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy. Patients with positive estrogen and/or progesterone receptors will begin anti-estrogen therapy after the last course of chemotherapy.

02

Conditions studied

  • Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 32 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

SCRI Development Innovations, LLC is the lead sponsor of 179 studies on the registry; 5 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

To be included in this study, you must meet the following criteria:

  • Histologically proven breast cancer
  • Females, age greater than 18 years
  • Ability to perform activites of daily living with minimal assistance
  • Normal cardiac function
  • Adequate bone marrow, liver and kidney
  • Signed informed consent prior to beginning specific protocol procedures

Exclusion criteria

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Prior systemic anticancer therapy for breast cancer
  • Prior anthracycline or taxane based chemotherapy for any malignancy
  • Pregnant or breast-feeding women.
  • Pre-existing moderate to severe motor or sensory neurotoxicity
  • Other serious illness or medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants

Interventions

06

What researchers measure

Primary outcomes

  1. Treatment-related toxicities

Secondary outcomes

  1. Overall response rate

  2. Overall survival

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Yardley DA, Burris HA 3rd, Farley CP, Barton JH, Peacock NW, Spigel DR, Greco FA, Hainsworth JD. A phase II feasibility trial of dose-dense docetaxel followed by doxorubicin/cyclophosphamide as adjuvant or neoadjuvant treatment for women with node-positive or high-risk node-negative breast cancer. Clin Breast Cancer. 2008 Jun;8(3):242-8. doi: 10.3816/CBC.2008.n.027. PubMed 18650154 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2004, a primary completion of Jun 2005 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 19, 2005
Start
Mar 2004
Primary completionActual
Jun 2005
CompletionActual
Jan 2009
Last update
Aug 4, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00193115
First posted
Sep 19, 2005
Start date
Mar 2004
Primary completion
Jun 2005
Completion
Jan 2009
Last update
Aug 4, 2010

Study contacts

Denise A. Yardley, MD
principal investigator · SCRI Development Innovations, LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

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.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

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

Studies of the drugs tested here: Docetaxel · Doxorubicin · Cyclophosphamide

Start the discussion