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Cancer, BreastPhase 2IMMUN-HERNCT03144947

Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Trastuzumab in HER2+ Breast Cancer Patients

A Phase 2 study testing Trastuzumab IV, Trastuzumab SC and Pertuzumab in people with Cancer, Breast, run by Gruppo Oncologico Italiano di Ricerca Clinica at 21 sites in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced /Inflammatory HER2-positive Breast Cancer (ImmunHER) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Breast
What is being tested?
Trastuzumab IV, Trastuzumab SC and Pertuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
21 sitesItaly
Study dates
29 Nov 2016to Nov 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previously untreated, infiltrating primary breast cancer with locally advanced, inflammatory, or early stage tumor (either greater than 2 cm in diameter or node positive) with no evidence of metastatic disease.
  • HER2 positivity (either immunohistochemistry 3+ or fluorescent in situ hybridization amplification).
  • Age 18 or older.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Availability of tumor tissue for biologic and molecular examination before starting primary treatment.
  • Left ventricular ejection fraction within the institutional range of normal.
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  • Normal organ and marrow function.
  • Adequate contraception methods for women of childbearing potential.
  • Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of 3 years.
  • Written informed consent.

Who cannot join

  • Either stage I or IV breast cancer.
  • Prior trastuzumab or pertuzumab.
  • Any prior chemotherapy.
  • Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
  • Undergone major surgery (e.g., intrathoracic, intra-abdominal or intra-pelvic) 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
  • Breast radiotherapy prior to starting study.
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  • Known hypersensitivity to the investigational drugs or any of their excipients.
  • Evidence of any disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an GOIRC-01-2016 ImmunHER Protocol Version 1.0, 11 April 2016 Page 6 of 140 investigational drug, or puts the patient at high risk for treatment-related complications.
  • Moderate/severe hepatic impairment (Child- Pugh B/C).
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Concurrent malignancy or malignancy within 3 years prior to study enrollment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or insitu carcinoma of the uterine cervix.
  • Pregnancy or breastfeeding (breast feeding should be discontinued to be enrolled in the study).
  • Women of childbearing potential that refusal to adopt adequate contraceptive measures.
  • Unwilling or unable to comply with the protocol. -

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Italy21 sites

  • UOC Oncologia-A.O. PAPA GIOVANNI XXIII Bergamo

    Bergamo, 24127

  • SSD di Oncologia Medica Addarii, Policlinico S. Orsola-Malpighi,

    Bologna, 40138

  • UOC di Oncologia. Azienda USL di Bologna, Ospedale Bellaria,

    Bologna, 40139

  • Divisione di Oncologia Medica - Ospedale di Bolzano,

    Bolzano, 39100

  • Breast Unit Spedali Civili di Brescia

    Brescia

  • Investigational Clinical Oncology - INCOIRCCS-Fondazione del Piemonte per l'Oncologia (FPO)

    Candiolo, 10060

  • UO di Oncologia Ematologia, Azienda Ospedaliero Universitaria di Ferrara

    Cona, Ferrara, 44124

  • Chirurgia generale ad indirizzo senologico-Breast Unit Azienda Istituti Ospitalieri di Cremona

    Cremona, 26100

  • Dipartimento di Medicina Interna e Specialità Mediche (DI.M.I.)-Università di Genova Clinica di Medicina Interna ad indirizzo oncologico

    Genova, 16132

  • UOC Oncologia Medica, Azienda ULSS21 di Legnago

    Legnago, Verona, 37045

  • Oncologia Medica, IRST. Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori, IRCCS di Meldola

    Meldola (FC), 47014

  • Dipartimento di Scienze Mediche e Chirurgiche, Materno Infantili e dell'adulto. Policlinico di Modena

    Modena, 41124

  • SC di Oncologia Medica, A.O. San Gerardo

    Monza, 20900

  • Oncologia Medica, Ospedale Sacro Cuore - Don Calabria - Negrar (VR)

    Negrar, Verona, 37024

  • Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica

    Parma, 43100

  • Dipartimento di Oncologia e Ematologia, UO di Oncologia Medica Azienda USL di Piacenza

    Piacenza, 29121

  • Struttura Complessa di OncologiaIRCCS- Istituto in Tecnologie Avanzate e Modelli Assistenziali in Oncologia Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

  • UO di Oncologia. Azienda USL di Rimini

    Rimini, 47923

  • Day Hospital, Ospedale di Sassuolo

    Sassuolo, 41049

  • U.O. di Oncologia Medica PO "S. Chiara"

    Trento, 38122

  • Oncologia Medica Az. Ospedaliera di Verona

    Verona, 37126

Other trials in Italy

About this study

Official title: Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients With Operable or Locally Advanced/Inflammatory HER2-positive Breast Cancer (ImmunHER)

Phase II, Open Label, Randomized, Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Subcutaneous (SC) Trastuzumab in Patients with Operable or Locally Advanced /Inflammatory HER2-positive Breast Cancer (ImmunHER)

Read the detailed description

Women with histologically confirmed HER2-positive breast cancer with locally advanced, inflammatory,or early stage tumor (either greater than 2 cm in diameter or node positive) with no evidence of metastatic disease.

Conditions
Cancer, Breast
Being tested
Trastuzumab IV, Trastuzumab SC, Pertuzumab, Docetaxel
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Trastuzumab IVBiological

    Also called Herceptin-150 mg

    Pre-randomization phase:

    FEC (fluorouracil 500 mg/m2; epirubicin 75 mg/m2; cyclophosphamide 500 mg/m2) x 3 cycles

    Post-randomization phase:

    Group A: Trastuzumab IV (8 mg/kg loading dose, followed by 6 mg/kg) plus pertuzumab IV (840 mg loading dose, followed by 420 mg) plus docetaxel (75 mg/m2)*, every 3 weeks for 4 cycles.

    by 420 mg) plus docetaxel (75 mg/m2)*, every 3 weeks for 4 cycles.

    *The dose of docetaxel may be escalated to 100 mg/m 2 at the investigator's discretion on subsequent cycles if the initial dose is well tolerated. After surgery, study patients will receive trastuzumab x 14 cycles using the same formulation (SC or IV) of the preoperative phase.

  • Trastuzumab SCBiological

    Also called Herceptin-600 mg/5 mL

    Pre-randomization phase:

    FEC (fluorouracil 500 mg/m2; epirubicin 75 mg/m2;

    Group B: Trastuzumab SC (fixed dose of 600 mg) plus pertuzumab IV (840 mg loading dose, followed by 420 mg) plus docetaxel (75 mg/m2)*, every 3 weeks for 4 cycles.

    *The dose of docetaxel may be escalated to 100 mg/m 2 at the investigator's discretion on subsequent cycles if the initial dose is well tolerated. After surgery, study patients will receive trastuzumab x 14 cycles using the same formulation (SC or IV) of the preoperative phase.

  • PertuzumabBiological

    Also called PerJeta 420 mg

    pertuzumab IV (840 mg loading dose, followed by 420 mg) weeks for 4 cycles (both arms)

  • DocetaxelDrug

    Also called Docetaxel 20 MG/ML

    docetaxel (75 mg/m2), every 3 weeks for 4 cycles (both arms). The dose of docetaxel may be escalated to 100 mg/m2 at the investigator's discretion on subsequent cycles if the initial dose is well tolerated.

Study groups in NCT03144947
Study groupRoleWhat they receive
Group AExperimentalTrastuzumab IV (8 mg/kg loading dose, followed by 6 mg/kg) plus pertuzumab IV (840 mg loading dose, followed by 420 mg) plus docetaxel (75 mg/m2)*, every 3 weeks for 4 cycles. After surgery, study patients will receive trastuzumab IV x 14 cycles
Receives: Biological: Trastuzumab IV; Biological: Pertuzumab; Drug: Docetaxel
Group BExperimentalTrastuzumab SC (fixed dose of 600 mg) plus pertuzumab IV (840 mg loading dose, followed by 420 mg) plus docetaxel (75 mg/m2)*, every 3 weeks for 4 cycles. After surgery, study patients will receive trastuzumab SC x 14 cycles
Receives: Biological: Trastuzumab SC; Biological: Pertuzumab; Drug: Docetaxel

What is being measured

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

  1. Tumor Infiltrating lymphocites (TIL) rate on residual disease after either IV trastuzumab or SC trastuzumab (see related paragraph)

    stromal lymphocytes will be scored quantitatively on H\&E stained whole-tumor slides as a continuous variable expressed as stromal percentage area within the tumor boundaries. For tumors with heterogeneous TILs, median values will be calculated from multiple counts from different tumor areas. Intra-epithelial TILs will also be recorded as well as tertiary lymphoid structures. Tumor regression will be scored based on recommended criteria.

    Measured: 6 months after last patient in

Secondary outcomes (5)

  1. Associations between biomarkers (TIL, Tumor specific lymphocyte cell activity (TLA), and Fc-gamma-R polymorphisms) and between each biomarker with clinical outcome variables.

    Measured: at baseline, 6 months and 5 years after last patient in

  2. Frequency of toxicity Events: frequency of moderate and severe toxicity events and drop-out rate due to theraphy related toxicity (NCICommon Toxicity Criteria v 4.0)

    Measured: 3.5 years

  3. HRQOL during study treatment based on FACT-B

    mean FACT-B scores assessed at enrolment and mean FACT-B scores assessed before surgery.

    Measured: at baseline, and 6 months after last patient in

  4. Complete pathological response rate by treatment arm

    Measured: 6 months after last patient in

  5. 5-year disease-free survival by treatment arm between treatment arms

    Measured: 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 posted9 May 2017
  2. Study start29 Nov 2016
  3. Primary completion15 Mar 2021 (estimated)
  4. Study completionNov 2021 (estimated)

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Non comparative, multi-center, open-label, neoadjuvant, randomized study, the purpose of randomization is to reduce bias owing to patient selection into treatments groups.
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03144947
Sponsor's protocol ID
GOIRC-01-2016
Acronym
IMMUN-HER
Status last verified
Oct 2020
First submitted
7 Apr 2017
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pellegrino B, Tommasi C, Serra O, Gori S, Cretella E, Ambroggi M, Frassoldati A, Bisagni G, Casarini C, Bria E, Carbognin L, Fiorio E, Mura A, Zamagni C, Gianni L, Zambelli A, Montemurro F, Tognetto M, Todeschini R, Missale G, Campanini N, Silini EM, Maglietta G, Musolino A. Randomized, open-label, phase II, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with locally advanced, inflammatory, or early HER2-positive breast cancer-Immun-HER trial (GOIRC-01-2016). J Immunother Cancer. 2023 Nov 28;11(11):e007667. doi: 10.1136/jitc-2023-007667.

    PubMed 38016718

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab IV, Trastuzumab SC and Pertuzumab in people with Cancer, Breast, run by Gruppo Oncologico Italiano di Ricerca Clinica at 21 sites in Italy.

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 10 inclusion and 14 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 14 Oct 2020. 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 Italy. 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?

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?

Tumor Infiltrating lymphocites (TIL) rate on residual disease after either IV trastuzumab or SC trastuzumab (see related paragraph) (time frame: 6 months after last patient in). 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 NCT03144947, 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 14 Oct 2020.

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