Breast CancerNCT00544505

Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)

A study testing Fluorouracil/Epirubicin/Cyclophosphamide in people with Breast Cancer, run by King Faisal Specialist Hospital & Research Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery (peri-operatively) (POCOB) (EORTC 10902) Read more about this study

Who is it for?: Ages Up to 70 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: Fluorouracil/Epirubicin/Cyclophosphamide
How many people: 10 participants
Where: No sites listed yet
Study dates: Sep 2007to Sep 2013
Phase: Interventional
Are there results?: None posted in the registry

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 Up to 70 years
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Disease Characteristics:
Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry
Stage T1c-4b, N0-1, M0
Hormone receptor status:
Not specified
No bilateral breast cancer

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Prior/Concurrent Therapy:
No previous treatment for breast cancer
Biologic therapy:
Not specified
Chemotherapy:
No previous chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Core needle biopsy or fine needle aspiration within 21 days prior to entry
Repeated core needle biopsy permitted
Patient Characteristics:
Age:
16 to 70
Sex:
Women only
Menopausal status:
Not specified
Performance status:
WHO 0-2
Hematopoietic:
WBC at least 4,000
Platelets at least 100,000
Hepatic:
Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)
Renal:
Creatinine no greater than 1.3 mg/dL (120 micromoles/L)
Cardiovascular:
No congestive heart failure
No significant arrhythmia
No bilateral bundle branch block
No recent myocardial infarction
No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)
Other:
No male breast cancer
No pregnant or nursing women
No second malignancy except adequately treated:
Nonmelanomatous skin cancer
Cervical cancer

Who cannot join

None listed.

About this study

Conditions: Breast Cancer
Being tested: Fluorouracil/Epirubicin/Cyclophosphamide
Medical subject headings: Breast Neoplasms

What participants receive

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

Fluorouracil/Epirubicin/CyclophosphamideDrug
Phase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer

What is being measured

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

Efficacy
Measured: overall

Timeline

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

Sep 2007Sep 2013

First posted16 Oct 2007 (estimated)
Study startSep 2007
Primary completionSep 2012 (estimated)
Study completionSep 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00544505
Sponsor's protocol ID: RAC#931-006
Status last verified: Dec 2011
First submitted: 15 Oct 2007
Last updated: 13 Dec 2011
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
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Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)
ClinicalTrials.gov ID: NCT00544505
Acronym / sponsor ID: RAC#931-006
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 10 participants (estimated)
Lead sponsor: King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
Study start: Sep 2007
Primary completion: Sep 2012 (estimated)
Study completion: Sep 2013 (estimated)
First posted: 16 Oct 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: Up to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (47 listed)

Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry
Stage T1c-4b, N0-1, M0
Not specified
No bilateral breast cancer
No previous treatment for breast cancer

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluorouracil/Epirubicin/CyclophosphamidePhase III Comparison of Preoperative vs Postoperative FEC (Fluorouracil/Epirubicin/Cyclophosphamide) in Women with Operable Breast Cancer	Drug	–

Primary outcome

Efficacy
Time frame: overall

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adnan Ezzat, MD principal investigator

King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia

Questions about this trial

What is this clinical trial studying?

A study testing Fluorouracil/Epirubicin/Cyclophosphamide in people with Breast Cancer, run by King Faisal Specialist Hospital & Research Center.

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 47 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Results are not available in the source record.

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?

Efficacy (time frame: overall). 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 NCT00544505.

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 13 Dec 2011.