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AzTrials

Breast CancerPhase 2NCT02846428

To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer

A Phase 2 study testing 5-Fluorouracil, Capecitabine and Cyclophosphamide in people with Breast Cancer, run by Hoffmann-La Roche at 21 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
5-Fluorouracil, Capecitabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
21 sitesFrance
Study dates
Mar 2004to Dec 2011
Phase
Phase 2
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females with a unilateral, non-inflammatory, non-multicentric, non-metastatic breast adenocarcinoma, not considered candidates for conservative management, and whose diagnosis had been histologically confirmed as T2-3, N0-1, M0 according to the tumor-nodes-metastasis (TNM) classification
  • Clinically or radiologically measurable lesion (in 2 dimensions)
  • Eastern Cooperative Oncology Group (ECOG) performance Status less than equal to (<=) 1

Who cannot join

  • Females presenting with brain metastases or a neurological or psychiatric disorder which could interfere with proper treatment compliance
  • Previous radiotherapy, chemotherapy, or hormonal therapy for breast cancer
  • Previous history of a malignancy in last 5 years other than cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
  • Serious concomitant infection
  • Pregnant or lactating females

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

France21 sites

  • Study site

    Bayonne, 64100

  • Study site

    Béziers, 34500

  • Study site

    Bourg-en-Bresse, 01012

  • Study site

    Colmar, 68024

  • Study site

    Dijon, 21079

  • Study site

    Hyères, 83400

  • Study site

    La Tronche, 38700

  • Study site

    Le Mans, 72037

  • Study site

    Limoges, 87042

  • Study site

    Lyon, 69437

  • Study site

    Marseille, 13385

  • Study site

    Montbéliard, 25209

  • Study site

    Montfermeil, 93370

  • Study site

    Nice, 06189

  • Study site

    Nîmes, 30029

  • Study site

    Paris, 75181

  • Study site

    Pierre-Bénite, 69310

  • Study site

    Saint-Herblain, 44805

  • Study site

    Strasbourg, 67010

  • Study site

    Toulouse, 31059

  • Study site

    Vannes, 56001

Other trials in France

About this study

Official title: An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in Females Presenting With Operable Breast Cancer

This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin + Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85). After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. During this period participants will be evaluated once a year on the anniversary date of randomization.

Conditions
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.

  • 5-FluorouracilDrug

    5-FU will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle during neoadjuvant treatment period for 4 cycles.

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine will be administered at 900 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.

  • CyclophosphamideDrug

    Cyclophosphamide will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.

  • DocetaxelDrug

    Docetaxel will be administered at 100 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period.

  • EpirubicinDrug

    Epirubicin will be administered at 100 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.

Study groups in NCT02846428
Study groupRoleWhat they receive
5-Fluorouracil + Epirubicin + CyclophosphamideActive comparatorNeoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of 5-FU + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.
Receives: Drug: 5-Fluorouracil; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Epirubicin
Capecitabine + Epirubicin + CyclophosphamideExperimentalNeoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of capecitabine + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.
Receives: Drug: Capecitabine; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Epirubicin

What is being measured

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

  1. Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\n

    Measured: Day 120 +/- 7 days

Secondary outcomes (12)

  1. Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification

    Measured: Day 120 +/- 7 days

  2. Percentage of participants with breast conserving surgery

    Measured: Day 120 +/- 7 days

  3. Percentage of participants with objective clinical response, assessed by World Health Organization (WHO) criteria

    Measured: Week 15

  4. Percentage of participants with clinical response, assessed by WHO criteria

    Measured: Week 15

  5. Percentage of participants with disease progression, assessed by WHO criteria

    Measured: Baseline up to 29 +/- 1 weeks

  6. Percentage of participants with abnormalities in bilateral mammography

    Measured: Day 85

  7. Percentage of participants who died

    Measured: Baseline up to 29 +/- 1 weeks

  8. Percentage of participants with abnormal left ventricular ejection fraction (LVEF)

    Measured: Days 1-85

  9. Percentage of participants with abnormal liver ultrasound

    Measured: Days 1-85

  10. Percentage of participants with abnormal Chest X-Ray

    Measured: Days 1-85

  11. Overall survival

    Measured: Baseline up to 5 years

  12. Disease free survival, according to WHO criteria

    Measured: Baseline up to 5 years

Timeline

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

  1. First posted27 Jul 2016 (estimated)
  2. Study startMar 2004
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02846428
Sponsor's protocol ID
ML16986
Status last verified
Jul 2016
First submitted
25 Jul 2016
Last updated
27 Jul 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5-Fluorouracil, Capecitabine and Cyclophosphamide in people with Breast Cancer, run by Hoffmann-La Roche at 21 sites in France.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\n (time frame: Day 120 +/- 7 days). 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 NCT02846428.

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 27 Jul 2016.

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