A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (... | NCT00190489

Studies
A Trial of Doxorubicin/Cyclophosphamide (AC), Docetaxel (D), and Alternating AC and D for Metastatic Breast Cancer

NCT00190489

Sponsor

Japan Clinical Oncology Group

Status

Completed

Last Update Posted

Sep 2, 2016Estimated

Enrollment

450

Phase

Phase 3

Conditions

Breast Cancer
Neoplasm Metastasis

Interventions

AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles
Docetaxel 60mg/m2 every 21 days for 6 cycles
AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
C000000179

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2016

Last Update Posted Date

Sep 2, 2016Estimated

Name	Class
Ministry of Health, Labour and Welfare, Japan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the clinical benefits of Docetaxel or alternating AC-Docetaxel in comparison with standard AC for metastatic breast cancer

Detailed Description

power to detect a 50% increase in median TTF at 0.025 one-sided alpha in AC vs. D and AC vs. AC-D.

Results: 441pts (146 in AC, 147 in D, 148 in AC-D) were randomized between 01/99 and 05/03. Major grade 3-4 toxicities were neutropenia (26/45/46% for AC/D/AC-D), febrile neutropenia (3/4/6%), nausea/vomiting (3/3/4%). There was no toxic death. One grade 4 diarrhea in AC-D and 1 secondary leukemia (APL) in D were reported. Response (CR/PR) rates were 30, 41, and 35% for AC, D, and AC-D respectively. Median TTF (AC, D, and AC-D) are 6.4, 6.4, and 6.7 months (p =.255 for AC vs. D, p =.275 for AC vs. AC-D), and median overall survival are 22.4, 25.7, and 25.0 months (p=.092 for AC vs. D, p=.076 for AC vs. AC-D). The same difference was shown by the adjusted Cox model.

Conclusions: No benefit was demonstrated in D and AC-D over AC in TTF, however, D and AC-D tended to be superior to AC in response rate and overall survival. Survival benefit of front-line docetaxel should be re-evaluated by further long follow-up.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AC (ADM 40mg/m2+CPA 500mg/m2) q21 days x 6 cycles	Drug
Docetaxel 60mg/m2 every 21 days for 6 cycles	Drug
AC and Docetaxel 60mg/m2 alternately q21 days for 6 cycles	Drug

Measure	Description	Time Frame
time to treatment failure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hormonal therapy-resistant MBC
ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy
No anthracyclines for MBC and no prior taxanes
At least 6 months from the completion of adjuvant chemotherapy
Measurable or evaluable lesions
Age: 20 to 75 years
PS: 0-3
WBC >= 4,000 /mm3 or ANC >=1,000 /mm3, Platelet >= 100,000 /mm3, SGOT/SGPT <= 1.5 x ULN, T-Bil <= 1.5 mg/dL, Cr <= 1.5 mg/dL
normal ECG
Written informed consent

Exclusion Criteria:

pregnant
malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment
Active infection
other cancer present within the last 5 years
previous stem cell transplantation
brain metastasis that requires emergent treatment
relapse within 6 months after completion anthracycline or during anthracycline
more than 250mg/m2 of anthracyclines
hypersensitivity of drug
interstitial pneumonitis or pulmonary fibrosis
positive HBs
antipsychotic medication
doctor's judgement

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shigemitsu Takashima, MD, PhD	National Shikoku Cancer Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center Hospital		Chuo-ku, Tsukiji, 5-1-1	Tokyo	104-0045	Japan

ID	Term
D001943	Breast Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes