Breast CancerPhase 3NCT00039546

Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery

A Phase 3 study testing cyclophosphamide, epirubicin hydrochloride and gemcitabine hydrochloride in people with Breast Cancer, run by Cancer Research Campaign Clinical Trials Centre at 46 sites in United Kingdom.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating women after surgery for breast cancer. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: cyclophosphamide, epirubicin hydrochloride and gemcitabine hydrochloride
Type of treatment: Surgery or procedure
How many people: Not given
Where: 46 sitesUnited Kingdom
Study dates: Aug 2001to not given
Phase: Phase 3
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

DISEASE CHARACTERISTICS:

Histologically confirmed newly diagnosed invasive breast cancer
Early stage disease
Completely resected disease
No more than 8 weeks since prior resection
Any nodal status
Indication for adjuvant chemotherapy
No metastatic disease
Hormone receptor status:
Estrogen receptor negative or weakly positive OR
Estrogen receptor positive AND progesterone receptor negative or weakly positive

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Not specified

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 3,000/mm3
Platelet count greater than 100,000/mm3
Hemoglobin greater than 9 g/dL

Hepatic:

Bilirubin normal
AST and ALT no greater than 1.5 times normal

Renal:

Creatinine no greater than 1.5 times normal

Other:

Fit to receive study chemotherapy
No active uncontrolled infection
No other malignancy within the past 10 years except basal cell carcinoma or carcinoma in situ of the cervix
No other concurrent medical or psychiatric problems that would preclude study
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics
No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy

Surgery:

See Disease Characteristics

Trial locations and contacts

46 sites in 1 country.

City, postcode or hospital

46 sites in 1 country

United Kingdom46 sites

Queen Elizabeth Hospital at University of Birmingham
Birmingham, England, B15 2TH
Cancer Research UK Clinical Trials Unit - Birmingham
Birmingham, England, B15 2TT
City Hospital - Birmingham
Birmingham, England, B18 7QH
Birmingham Heartlands and Solihull NHS Trust -Teaching
Birmingham, England, B9 5SS
Queen's Hospital, Burton
Burton-on-Trent, England, DE14 3QH
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 2QQ
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, CF4 7XL
Broomfield Hospital
Chelmsford, Essex, England, CM1 5ET
Essex County Hospital
Colchester, England, C03 3NB
Walsgrave Hospital
Coventry, England, CV2 2DX
Dorset County Hospital
Dorchester, England, DT1 2JY
Hairmyres Hospital
East Kilbride, G75 8RG
Western General Hospital
Edinburgh, Scotland, EH4 2XU
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Royal Infirmary - Castle
Glasgow, Scotland, G4 0SF
Princess Royal Hospital
Hull, England, HU8 9HE
Hull Royal Infirmary
Hull, HU3 2KZ
Hinchingbrooke Hospital
Huntingdon, England, PE18 6NT
King George Hospital
Ilford, Essex, England, IG3 8YB
Crosshouse Hospital
Kilmarnock, England, KA2 OBE
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, LS16 6QB
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
St. George's Hospital
London, England, SW17 0QT
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Northampton General Hospital NHS Trust
Northampton, England
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
Derriford Hospital
Plymouth, England, PL6 8DH
Glan Clywd District General Hospital
Rhyl, Denbighshire, LL 18 5UJ
Oldchurch Hospital
Romford, England, RM7 OBE
Thornbury Hospital
Sheffield, England, S10 3BR
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Royal Shrewsbury Hospital
Shrewsbury, England
West Suffolk Hospital
Suffolk, England, IP33 2QZ
Singleton Hospital
Swansea, SA 2 8QA
Torbay Hospital
Torquay Devon, England, TQ2 7AA
Walsall Manor Hospital
Walsall, England, WS2 9PS
Sandwell General Hospital
West Bromwich, England, B71 4HJ
Morriston Hospital NHS Trust
West Glamorgen, SA6 6NL
Good Hope Hospital Trust
West Midlands, England, B75 7RR
Worcester Royal Hospital
Worcester, England, WR5 1JG

Other trials in United Kingdom

About this study

Official title: 'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery for breast cancer.

Read the detailed description

OBJECTIVES:

Compare the 5-year and 10-year disease-free survival and overall survival of women with completely resected early stage breast cancer treated with adjuvant paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine.
Compare the toxicity, dose-intensity, and tolerability of these regimens in these patients.
Compare the serious adverse events in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (negative vs 1-3 vs 4 or more), age (50 and under vs over 50), estrogen receptor status (negative vs weakly positive vs positive), concurrent radiotherapy (no vs yes), HER2 status (3+ overexpression vs other vs not measured), and country. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive epirubicin IV, cyclophosphamide IV, and paclitaxel IV over 3 hours on day 1. Patients also receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive epirubicin, cyclophosphamide, and paclitaxel as in arm I.

Patients are followed every 3 months for 6 months, every 6 months for 3 years, and then annually for 6 years.

PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 3-4 years.

Conditions: Breast Cancer
Being tested: cyclophosphamide, epirubicin hydrochloride, gemcitabine hydrochloride, paclitaxel, adjuvant therapy
Keywords: stage I breast cancer, stage II breast cancer
Medical subject headings: Breast Neoplasms

What participants receive

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

cyclophosphamideDrug
epirubicin hydrochlorideDrug
gemcitabine hydrochlorideDrug
paclitaxelDrug
adjuvant therapyProcedure or surgery

Timeline

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

Aug 2001?

First posted27 Jan 2003 (estimated)
Study startAug 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised

IDs, dates and publications

ClinicalTrials.gov ID: NCT00039546
Sponsor's protocol ID: CRC-TU-TANGO
Other IDs: CDR0000069396, EU-20058
Status last verified: May 2005
First submitted: 6 Jun 2002
Last updated: 7 Aug 2013
Results posted: No

Publications

Earl HM, Hiller L, Howard HC, Dunn JA, Young J, Bowden SJ, McDermaid M, Waterhouse AK, Wilson G, Agrawal R, O'Reilly S, Bowman A, Ritchie DM, Goodman A, Hickish T, McAdam K, Cameron D, Dodwell D, Rea DW, Caldas C, Provenzano E, Abraham JE, Canney P, Crown JP, Kennedy MJ, Coleman R, Leonard RC, Carmichael JA, Wardley AM, Poole CJ; tAnGo trial collaborators. Addition of gemcitabine to paclitaxel, epirubicin, and cyclophosphamide adjuvant chemotherapy for women with early-stage breast cancer (tAnGo): final 10-year follow-up of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):755-769. doi: 10.1016/S1470-2045(17)30319-4. Epub 2017 May 4.
PubMed 28479233

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?

See locations

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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
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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer
ClinicalTrials.gov ID: NCT00039546
Acronym / sponsor ID: CRC-TU-TANGO
Conditions: Breast Cancer
Keywords: stage I breast cancer, stage II breast cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Lead sponsor: Cancer Research Campaign Clinical Trials CentreUniversity, hospital or other
Study start: Aug 2001
First posted: 27 Jan 2003 (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.

Detailed description

OBJECTIVES:

Compare the 5-year and 10-year disease-free survival and overall survival of women with completely resected early stage breast cancer treated with adjuvant paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine.
Compare the toxicity, dose-intensity, and tolerability of these regimens in these patients.
Compare the serious adverse events in patients treated with these regimens.

Arm I: Patients receive epirubicin IV, cyclophosphamide IV, and paclitaxel IV over 3 hours on day 1. Patients also receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive epirubicin, cyclophosphamide, and paclitaxel as in arm I.

Patients are followed every 3 months for 6 months, every 6 months for 3 years, and then annually for 6 years.

PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 3-4 years.

Study design

Primary purpose: Treatment
Allocation: Randomised

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
cyclophosphamide	Drug	–
epirubicin hydrochloride	Drug	–
gemcitabine hydrochloride	Drug	–
paclitaxel	Drug	–
adjuvant therapy	Procedure or surgery	–

Primary outcome

Not reported in the source record.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Derived from this study: PubMed 28479233Earl HM, Hiller L, Howard HC, Dunn JA, Young J, Bowden SJ, McDermaid M, Waterhouse AK, Wilson G, Agrawal R, O'Reilly S, Bowman A, Ritchie DM, Goodman A, Hickish T, McAdam K, Cameron D, Dodwell D, Rea DW, Caldas C, Provenzano E, Abraham JE, Canney P, Crown JP, Kennedy MJ, Coleman R, Leonard RC, Carmichael JA, Wardley AM, Poole CJ; tAnGo trial collaborators. Addition of gemcitabine to paclitaxel, epirubicin, and cyclophosphamide adjuvant chemotherapy for women with early-stage breast cancer (tAnGo): final 10-year follow-up of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):755-769. doi: 10.1016/S1470-2045(17)30319-4. Epub 2017 May 4.

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.

Helen Howard, PhD study chair

Cancer Research Campaign Clinical Trials Centre

46 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00039546, which also lists 1 linked publication.

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 7 Aug 2013.