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Breast CancerPhase 1/2NCT00129896

Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients

A Phase 1/2 study testing Myocet, Taxotere and Herceptin in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 16 sites in Spain.

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 is an open-label study to assess the efficacy and tolerability of the combination Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients. HER2 status will be confirmed centrally by fluorescence in situ hybridization (FISH). 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?
Myocet, Taxotere and Herceptin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
16 sitesSpain
Study dates
Jan 2004to Feb 2010
Phase
Phase 1/2
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

  • Written informed consent.
  • Breast cancer stages II and IIIA with histological diagnoses by true-cut.
  • Breast cancer tumours overexpressing HER2neu, centrally confirmed by FISH.
  • No evidence of metastasis: bilateral mammography, thorax x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.
  • Estrogen and progesterone hormone receptor status, determined before study registration.
  • Age >= 18 years old.
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  • Performance status (Karnofsky index) >= 80.
  • Adequate cardiac function by LVEF in the previous 14 days.
  • Hematology: neutrophils >= 2.0 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10 g/dl.
  • Adequate hepatic function: total bilirubin <= 1x upper normal limit (UNL); SGOT and SGPT <= 2.5xUNL; alkaline phosphatase <= 2.5xUNL.
  • Adequate renal function: creatinine <= 1xUNL; creatinine clearance >= 60 ml/min.
  • Patients able to comply with study treatment and follow-up.
  • Negative pregnancy test in the previous 14 days.
  • Adequate contraceptive method during the study and up to 3 months after definitive surgery.

Who cannot join

  • HER2neu negative tumours.
  • Prior systemic therapy for breast cancer.
  • Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy.
  • Prior radiotherapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant or lactating women.
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  • Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCI CTC]).
  • Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen.
  • Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
  • Chronic treatment with corticosteroids.
  • Contraindications for administration of corticosteroids, anthracyclines, docetaxel, trastuzumab or egg derivates.
  • Concomitant treatment with other therapy for cancer.
  • Males.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Spain16 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario Virgen de los Lirios

    Alcoy, Alicante, 03804

  • Hospital de la Ribera

    Alzira, Valencia, 46600

  • Hospital Infanta Cristina

    Badajoz, 06080

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Onkologikoa

    Donostia / San Sebastian, Guipúzcoa, 20012

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital Universitario Lucus Augusti

    Lugo, 27004

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga, 29010

  • Althaia-Xarxa Assistencial de Manresa

    Manresa, Barcelona, 08243

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona, 08208

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Universitario La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Open-label Phase I-II Clinical Trial to Evaluate Treatment With Myocet/Taxotere/Herceptin as Primary Chemotherapy Treatment for HER2neu Positive Breast Cancer Patients

This is an open-label study to assess the efficacy and tolerability of the combination Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients. HER2 status will be confirmed centrally by fluorescence in situ hybridization (FISH).

Phase I: Initial doses will be:

Read more

Myocet: 50-60 mg/m² day 1 every 3 weeks; Taxotere 60-75 mg/m² day 1 every 3 weeks; and Herceptin (4) 2 mg/kg weekly.

Sample size will depend on the number of patients recruited during dose escalation. Three patients must be recruited in each dose level. If one out of three experiences a dose-limiting toxicity (DLT), 3 more patients must be recruited in the same dose level. Considering that there are 4 dose levels to be tested, the estimated number of patients is 9 to 24. Patients receiving the recommended dose (RD) will be incorporated into phase II of the study.

Read the detailed description

Phase II: The average pathological complete response rate reported in other trials is around 11%. The investigators expect to achieve an increase of 14% on this rate; that is, they expect a pathological response rate of 25%. With a= 0.05 and β=0.2, 18 patients are initially needed. If at least 3 pathological complete responses are achieved, recruitment will continue to up to 53 patients. At least 10 pathological complete responses are needed to probe the hypothesis. Considering a 10% post-randomization drop-out rate, a total of 59 patients must be recruited for the trial.

Conditions
Breast Cancer
Being tested
Myocet, Taxotere, Herceptin
Keywords
Her2neu positive breast cancer., Neoadjuvant treatment.
Medical subject headings
Breast Neoplasms

What participants receive

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

  • MyocetDrug

    Also called Lyposomal Doxorubicin

    Myocet®: 60-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles

  • TaxotereDrug

    Also called Docetaxel

    Taxotere® 70-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles

  • HerceptinDrug

    Also called Trastuzumab

    Herceptin® (4) 2 mg/kg (vía IV) Semanal for 6 cycles

Study groups in NCT00129896
Study groupRoleWhat they receive
Myocet+Taxotere+HerceptinExperimentalMyocet 50 mg/m2; Taxotere 60 mg/m2; Herceptín 4 mg/Kg (first dose) and in the following cycles 2 mg/Kg
Receives: Drug: Myocet; Drug: Taxotere; Drug: Herceptin

What is being measured

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

  1. Tolerability (Phase I): Recommended Doses of the combination treatment

    Recommended Doses of the combination treatment

    Measured: up to 24 months since last patient included in the Phase I

  2. Efficacy (Phase II): Percentage (%) pathological Complete Response achieved according to Miller and Payne Criteria

    % pathological Complete Response achieved according to Miller and Payne Criteria

    Measured: up to 24 months since last patient included in the Phase II

Secondary outcomes (6)

  1. Clinical response rates

    Clinical responses evaluated by radiological imaging

    Measured: up to 6 months since last patient treatment

  2. Surgery type (conservative surgery versus mastectomy)

    % conservative or mastectomy surgery

    Measured: up to 7 months since last patient treatment

  3. Potential cardiac toxicity

    Left ventricular ejection fraction [LVEF] by multiple-gated acquisition [MUGA])

    Measured: up to 12 months since last patient included

  4. Safety: Adverse Events evaluated according to NCI CTC v2.0

    Adverse Events evaluated according to NCI CTC v2.0

    Measured: 24 months since last patient included

  5. Post-surgery node status

    according to Miller and Payne Criteria

    Measured: up to 7 months since last patient treatment

  6. Molecular changes in blood and tissue exams

    Different biomarkers evaluated

    Measured: 24 months

Timeline

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

  1. First posted12 Aug 2005 (estimated)
  2. Study startJan 2004
  3. Primary completionDec 2008
  4. Study completionFeb 2010

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129896
Sponsor's protocol ID
GEICAM 2003-03
Status last verified
Mar 2023
First submitted
11 Aug 2005
Last updated
6 Mar 2023
Results posted
No
Data monitoring committee
No

Publications

  • Anton A, Ruiz A, Plazaola A, Calvo L, Segui MA, Santaballa A, Munoz M, Sanchez P, Miguel A, Carrasco E, Lao J, Camps J, Alfaro J, Antolin S, Camara MC. Phase II clinical trial of liposomal-encapsulated doxorubicin citrate and docetaxel, associated with trastuzumab, as neoadjuvant treatment in stages II and IIIA HER2-overexpressing breast cancer patients. GEICAM 2003-03 study. Ann Oncol. 2011 Jan;22(1):74-79. doi: 10.1093/annonc/mdq317. Epub 2010 Jul 5.

    PubMed 20603435

  • Anton A, Ruiz A, Segui MA, Calvo L, Munoz M, Lao J, Sancho F, Fernandez L. Phase I clinical trial of liposomal-encapsulated doxorubicin citrate and docetaxel, associated with trastuzumab, as neo-adjuvant treatment in stages II and IIIA, HER2-overexpressing breast cancer patients. GEICAM 2003-03 study. Ann Oncol. 2009 Mar;20(3):454-9. doi: 10.1093/annonc/mdn663. Epub 2008 Dec 11.

    PubMed 19074216

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Myocet, Taxotere and Herceptin in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 16 sites in Spain.

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 14 inclusion and 13 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 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Spain. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Tolerability (Phase I): Recommended Doses of the combination treatment (time frame: up to 24 months since last patient included in the Phase I). The study lists 2 primary outcomes in all. 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 NCT00129896, which also lists 2 linked publications.

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 6 Mar 2023.

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