Capecitabine in Women With Operable Breast Cancer | NCT00148720

Studies
Capecitabine in Women With Operable Breast Cancer

NCT00148720

Sponsor

Dana-Farber Cancer Institute

Status

Terminated

Last Update Posted

Nov 11, 2015Estimated

Enrollment

80Estimated

Phase

Phase 2

Conditions

Invasive Breast Carcinoma
Primary Invasive Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer

Interventions

Capecitabine

Countries

United States

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrual

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Sep 2007Actual

Completion Date

Not provided

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 8, 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

Nov 9, 2015

Last Update Posted Date

Nov 11, 2015Estimated

Name	Class
Hoffmann-La Roche	INDUSTRY
Beth Israel Deaconess Medical Center	OTHER
Brigham and Women's Hospital	OTHER

Description Module

Brief Summary

The purpose of this study is to find out what effects (good and bad) taking capecitabine for 12 weeks before surgery will have on women with breast cancer.

Detailed Description

Prior to the start of treatment, patients will have a small metal clip inserted into the tumor bed to identify the tumor site to the surgeon. At that time, a needle biopsy of the breast tumor or a sentinel (underarm) lymph node biopsy will also be performed.
Patients will take capecitabine orally twice daily for 14 days. This treatment will repeat every 21 days (1 cycle). Patients will receive 4 cycles of this treatment.
A physical exam and blood work will be done every three weeks after starting therapy to monitor side effects.
After two weeks of capecitabine a biopsy from the tumor will be done to generate information about the characteristics of the tumor that may respond to capecitabine.
After completing 4 cycles (12 weeks) of capecitabine, patients will then undergo surgery to remove any remaining breast cancer (lumpectomy or mastectomy). Post-surgical treatment (radiation, chemotherapy, and hormonal therapy) is at the discretion of the patients physician.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Name	Type	Description	Arm Group Labels	Other Names
Capecitabine	Drug	Taken orally twice a day for 14 days and treatment will repeat every 21 days (1 cycle) for 4 cycles

Measure	Description	Time Frame
To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological confirmation of primary invasive breast cancer
Stage I-III operable breast cancer.
Primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation
Women greater than 18 years of age
ECOG performance status 0-1
WBC > 4000/mm3
Platelet count > 100,000/mm3
SGOT < 2x ULN
Calculated creatinine clearance > 50ml/min

Exclusion Criteria:

Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study.
Pregnant or breast-feeding women
Inflammatory breast cancer
HER2 positive disease
History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency
Uncontrolled intercurrent illness
Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant.
Excisional biopsy performed prior to enrollment
Uncontrolled coagulopathy
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ian Krop, MD, PhD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02115	United States
Faulkner Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24464780	Result	Tolaney SM, Jeong J, Guo H, Brock J, Morganstern D, Come SE, Golshan M, Bellon J, Winer EP, Krop IE. A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer. Cancer Med. 2014 Apr;3(2):293-9. doi: 10.1002/cam4.164. Epub 2014 Jan 27.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines