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HER-2 Positive Breast CancerPhase 2met-HEReMYTANCT02488564

A Study of Liposomal Doxorubicin+Docetaxel+Trastuzumab+Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer

A Phase 2 study testing Liposomal doxorubicin, Docetaxel and Trastuzumab in people with HER-2 Positive Breast Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 9 sites in Italy.

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

It is a multicenter, open-label, two stage phase II trial, to assess activity, safety and potential early predictors of response in neoadjuvant setting. Patients with operable breast cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer (T4a-d, N0-N2, M0) with overexpression or… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HER-2 Positive Breast Cancer
What is being tested?
Liposomal doxorubicin, Docetaxel and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
9 sitesItaly
Study dates
17 Dec 2014to 17 Mar 2020
Phase
Phase 2

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed breast cancer
  • HER2 overexpressing cancer
  • Patients with operable breast cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer (T4a-d, N0-N2, M0) (AJCC 7th edition 2010).
  • No prior therapy for breast cancer
  • Both sexes, age ≥ 18 years and < 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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  • Life expectancy > 3 months
  • Neutrophil count ≥ 2 x 109/ L, leukocytes count ≥ 3 x 109/ L and platelet count ≥ 100 x 109/ L
  • Total bilirubin ≤ 1 upper-normal limits (UNL) of the Institutional normal values and alanine aminotransferase (ASAT (GOT) and/or alanine aminotransferase ALAT (GPT) ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL. Patients with ASAT and/or ALAT > 1.5 UNL and alkaline phosphatase > 2.5 UNL aren't eligible for the trial.
  • Creatinine ≤ 1.5 mg/dL
  • Left ventricular ejection fraction (LVEF) ≥ 50% (evaluated by echocardiogram or multiple gated acquisition scan (MUGA) scan -only one method must be employed for each patient)
  • Written informed consent
  • Homa Index calculated using the Matthews'formula

Who cannot join

  • Prior chemotherapy or radiotherapy for breast cancer.
  • History of prior malignancy in the last 10 years (other than non-melanoma skin cancer or excised cervical carcinoma in situ).
  • Other serious illness or medical condition
  • Congestive heart failure or angina pectoris even if medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia
  • History of significant neurologic or psychiatric disorders including dementia or seizures
  • Active infection
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  • Concurrent treatment with other experimental drugs.
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  • Geographic inaccessibility to treatment and followup
  • Pregnant and lactating women
  • Diabetes-insulin dependant and non-insulin dependant

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Italy9 sites

  • Oncologia Medica AOU Ferrara

    Ferrara, FE, 44124

  • Day Hospital Oncologico, Ospedale Guastalla

    Guastalla, 42016

  • Oncologia Medica AUSL Imola

    Imola, 40133

  • IRST Oncologia medica

    Meldola, FC, 47014

  • Oncologia Medica, Policlinico di Modena

    Modena, MO, 41100

  • Oncologia Medica AOU Parma

    Parma, 43100

  • Oncologia Medica Ospedale Guglielmo da Saliceto

    Piacenza, PC, 29121

  • Oncologia , IRCCS azienda ospedaliera S.Maria Nuova

    Reggio Emilia, RE, 42123

  • U.O Oncologia AUSLdella Romagna

    Rimini, RN, 47923

Other trials in Italy

About this study

Official title: Clinical and Translational Phase II Study of Liposomal Doxorubicin Plus Docetaxel and Trastuzumab with Metformin As Primary Systemic Therapy for Operable and Locally Advanced Recombinant Human ErbB-2 (HER2) Positive Breast Cancer

It is a multicenter, open-label, two stage phase II trial, to assess activity, safety and potential early predictors of response in neoadjuvant setting. Patients with operable breast cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer (T4a-d, N0-N2, M0) with overexpression or amplification of HER2 (AJCC 7th edition 2010) are included in the study.

The primary objective is to evaluate the pathological complete response rate (pCR).

Read more

The secondary objectives are:

  • to evaluate the clinical response rate (RR).
  • to evaluate the feasibility and systemic tolerance, with particular attention to cardiac toxicity.
  • to evaluate the conservative surgery rate.

Total duration of the trial is 36 months; planned treatment are 6 cycles of chemotherapy. At every cycle (every 21 days) will be administered:

Day 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9: Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first infusion loading dose, then 2 mg/kg/week for subsequent injections. Day -13 to 0: Metformin is administered as single agent. From day -13 to day -11, Metformin 1000 mg will be administered once a day; from day -10 Metformin 1000 mg will be administered twice a day continuously until end of the study treatment.

Read the detailed description

Multi-center, open-label phase II trial to assess activity of this chemotherapy scheme evaluated by pathologic complete response rate (pCR).

Planned treatment are 6 cycles of chemotherapy.

At every cycle (every 21 days) will be administered:

Day 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9: Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first infusion loading dose, then 2 mg/kg/week for subsequent injections Day -13 to 0: Metformin is administered as single agent. From day -13 to day -11, Metformin 1000 mg will be administered once a day; from day -10 Metformin 1000 mg will be administered twice a day continuously until end of the study treatment.

Total duration of the trial: 36 months Enrollment period: 24 months Treatment: maximum of 6 cycles (5 months) per patient Follow-up for recurrence: every six months for 5 years, than once a year until 10 years after surgery.It's necessary to recruit 46 patients for clinical objectives evaluation.

Being tested
Liposomal doxorubicin, Docetaxel, Trastuzumab, Metformin
Keywords
HER-2 Positive Breast Cancer, operable breast cancer, locally advanced breast cancer, no prior therapy, pCR

What participants receive

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

  • Liposomal doxorubicinDrug

    Also called Myocet®

    50 mg/m2 by intravenous infusion over a period of 1 hour on day 1 of each cycle repeated every 21 days. A final concentration of between 0.4 to 1.2 mg/ml doxorubicin hydrochloride, is required

  • DocetaxelDrug

    Also called taxotere

    30 mg/m2 by intravenous infusion over a period of 1 hour on day 2 and 9, every 3 week.They will be given for 6 cycles.

  • TrastuzumabDrug

    Also called herceptin

    4 mg/kg for the first administration (day 2 cycle 1) and 2 mg/kg for subsequent administrations. Trastuzumab will be given weekly for the duration of chemotherapy (day 2, 9, 16), then will be administered at the dose of 6 mg/Kg every 3 weeks until completion of 52 weeks of treatment.

  • MetforminDrug

    It is administered as single agent from day -13 to 0. From day -13 to day -11, Metformin 1000 mg will be administered once a day; from day -10, Metformin 1000 mg will be administered twice a day continuously until end of the study treatment.

Study groups in NCT02488564
Study groupRoleWhat they receive
Liposomal doxorubicin +Docetaxel+Trastuzumab+MetforminExperimentalDay 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9: Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first infusion loading dose, then 2 mg/kg/week for subsequent injections. Day -13 to 0: Metformin is administered as single agent. From day -13 to day -11, Metformin 1000 mg will be administered once a day; from day -10 Metformin 1000 mg will be administered twice a day continuously until end of the study treatment.
Receives: Drug: Liposomal doxorubicin; Drug: Docetaxel; Drug: Trastuzumab; Drug: Metformin

What is being measured

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

  1. Pathologic complete response rate(pCR)

    Complete pathologic response will be defined as no invasive residuals in breast and axillary nodes. In situ tumor residuals are considered as complete response rate

    Measured: up to 36 months

Secondary outcomes (3)

  1. clinical response rate (RR)

    The clinical response rate (RR) will be including Pathological Complete Response, Clinical Complete Response and Clinical Partial Response (Response Evaluation Criteria in Solid Tumors (RECIST) criteria).

    Measured: up to 36 months

  2. evaluation of toxicity

    All patients will be evaluable for toxicity from the time of their first treatment with Metformine. The toxicity will be recorded according to the CTC-AE, version 4.0 in the safety population until Follow-up is completed (36 months)

    Measured: up to 36 months

  3. conservative surgery rate

    evaluation of the number of patients who underwent conservative surgery

    Measured: up to 36 months

Timeline

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

  1. First posted2 Jul 2015 (estimated)
  2. Study start17 Dec 2014
  3. Primary completionOct 2018
  4. Study completion17 Mar 2020

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02488564
Sponsor's protocol ID
IRST174.09
Acronym
met-HEReMYTA
Status last verified
Jan 2025
First submitted
17 Jun 2015
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No

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