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To Reduce the Use of Chemotherapy in Elderly Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) (TOUCH)

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ClinicalTrials.gov Identifier: NCT03644186
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
Pfizer
Hoffmann-La Roche
Information provided by (Responsible Party):
International Breast Cancer Study Group

Brief Summary:
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of elderly patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

Condition or disease Intervention/treatment Phase
Breast Cancer Estrogen Receptor Positive Tumor HER2-positive Breast Cancer Drug: Paclitaxel Drug: Trastuzumab Drug: Pertuzumab Drug: Palbociclib Drug: Letrozole Phase 2

Detailed Description:

TOUCH is an open label, international, phase II neoadjuvant trial which will assess the treatment of elderly patients with hormone receptor positive / human epidermal growth factor receptor-2 (HER2) positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

The neo-adjuvant setting was chosen to evaluate these therapy combinations in a short time-frame and to provide access to biomaterial both at baseline and after the end of the treatment, at surgery. Biopsy specimens will be analyzed at the end of the trial by gene-expression profiling to assess RBsig status. This marker may represent a tool to identify the participants who are more likely to benefit from a chemotherapy-free regimen in this population.

Palbociclib is a potent, highly selective, reversible, orally active, inhibitor of cyclin-dependent kinases 4 and 6 (CDK 4/6), therefore inhibiting cell growth and can be safely and effectively administered to older patients without need for dose adjustment based solely on age. Treatment de-escalation, namely harnessing and taking maximum advantage of targeted therapies vs conventional treatment (chemotherapy) in order to limit side effects, is particularly appealing in the older population.

Clinical data from the HR positive /HER2 negative setting show that combinations of palbociclib and letrozole are safe and effective. These combinations have not yet been tested in the HR positive /HER2 positive population that the investigators include in this trial. However, combinations of trastuzumab and endocrine treatment (ET), including letrozole have shown to be safe and to have some additional activity compared to ET alone in the HR positive /HER2 positive population. Therefore, the role of palbociclib in addition to letrozole and trastuzumab plus pertuzumab needs to be further studied.

Current standard of care for treatment of HER2 positive BC incorporates chemotherapy and anti-HER2 agents, with chemotherapy regimens of sequential anthracyclines and taxanes, used as single agents or in combination with other chemotherapy drugs. Trastuzumab is often administered concurrently with a single agent taxane to avoid the possible additive cardiac toxicity of combinations of anthracycline containing regimens and trastuzumab.

A regimen of weekly paclitaxel and trastuzumab plus pertuzumab was chosen as the comparator arm in this trial. More aggressive chemotherapy may not be justified in this population and trial participants may receive additional treatment after surgery, at the discretion of the treating doctor.

Preclinical and clinical rationale exists to support the proposal that palbociclib may represent a valuable option for increasing the activity of ET and anti-HER2 agents, such that a triple combination with these agents could prove superior to a standard treatment with chemotherapy and anti-HER2 agents.

The investigators hypothesize that the combination of palbociclib, letrozole and trastuzumab plus pertuzumab proposed in this trial will be more efficacious compared to the combinations of anti-HER2 agents and ET reported in other trials.

Around 40% of BCs occur in women aged 65 and older. Of these, 10-15% have tumors that overexpress HER2. Elderly patients are generally underrepresented in clinical trials and may benefit from anti-HER2 agents as much as the younger population. Elderly patients with HR positive /HER2 positive BC represent a unique group of patients with an unmet clinical need. This population is the focus of the TOUCH trial.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Open-label, Multicentre, Randomized Trial of Neoadjuvant Palbociclib in Combination With Hormonal Therapy and HER2 Blockade Versus Paclitaxel in Combination With HER2 Blockade for Elderly Patients With Hormone Receptor Positive/HER2 Positive Early Breast Cancer
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Paclitaxel plus trastuzumab and pertuzumab
Receiving paclitaxel 80mg/m2 i.v. on day 1, 8, 15 every 28 days for 4 cycles, trastuzumab 600mg s.c. every 3 weeks for a total of 5 doses and pertuzumab 840 mg i.v. loading dose followed by 420 mg i.v. every 3 weeks for a total of 5 doses.
Drug: Paclitaxel
Chemotherapy plus HER2 Blockade
Other Name: Paclitaxel Sandoz

Drug: Trastuzumab
Chemotherapy plus HER2 Blockade
Other Name: Herceptin

Drug: Pertuzumab
Chemotherapy plus HER2 Blockade
Other Name: Perjeta

Experimental: Palbociclib plus letrozole plus trastuzumab and pertuzumab
Receiving palbociclib 125 mg/day orally for 21 days followed by 7 day's rest, for four 28 day cycles, letrozole 2.5 mg/day orally for 16 weeks and trastuzumab 600 mg s.c. every 3 weeks for a total of 5 doses and pertuzumab 840 mg i.v. loading dose followed by 420 mg i.v. every 3 weeks for 5 doses.
Drug: Palbociclib
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Name: Ibrance

Drug: Letrozole
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Name: Femara

Drug: Trastuzumab
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Name: Herceptin

Drug: Pertuzumab
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Name: Perjeta




Primary Outcome Measures :
  1. Pathological complete response (pCR) [ Time Frame: Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped. ]
    Defined as absence of invasive tumour cells in the breast and in the axillary lymph nodes at the time of surgery (ypT0/ypTis ypN0) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual. The presence of in situ cancer after trial treatment in the absence of residual invasive disease constitutes a pCR.


Secondary Outcome Measures :
  1. Pathological complete response (pCR) in the breast [ Time Frame: Assessed at the time of breast surgery within 30 days of completion of a treatment period of up to 16 weeks. All patients who are discontinued from treatment for any reason will be documented within 30 days after surgery. ]
    Defined as the absence of invasive tumour cells in the breast at the time of surgery (ypT0/ypTis) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual..

  2. Objective response [ Time Frame: Tumour assessments will be performed by ultrasound and mammography at screening (prior to start of treatment), and before surgery. Tumour measurements by caliper will be assessed at the same time points and at the end of cycle 2 (each cycle is 28 days). ]
    Defined as the number of patients with partial or complete response measured physically by caliper and by ultrasound and mammography. Response will be assessed using World Health Organisation tumour measurement and response criteria.

  3. Frequency of reported adverse events [ Time Frame: From the time informed consent is signed, during treatment and until 30 days after surgery. If there is no surgery, adverse events will be collected until 30 days after treatment stops. ]
    Defined by frequency of all grades for targeted adverse events, all grade 3 for non-targeted events and grade ≥2 for non-targeted events requiring medical attention according to CTCAE version 5. For each adverse event, the frequency of patients by worst grade of the adverse event will be summarized and tabulated by treatment.

  4. Rate of breast conserving surgery (BCS) [ Time Frame: Assessed at 35 months after randomization of the first patient. ]
    Defined as the number of patients undergoing BCS, divided by the number of patients in the assessable population (subset of the randomized population with RBsig status successfully determined who received at least 1 dose of medication).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed invasive breast cancer, with the following characteristics:
  • Early breast cancer with tumor size >1 cm (as measured by at least one of the required examination methods of clinical examination, mammography and ultrasonography); No clinical evidence of regional lymph node metastasis (N0), or, nodal involvement limited to clinically detectable metastasis to movable ipsilateral level I, II axillary lymph node(s) (N1); No evidence of metastasis (M0).
  • Female aged 65 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Primary tumor must have positive estrogen receptor (ER) ≥10%
  • Primary tumor must be HER2-positive (by IHC and/or ISH)
  • Baseline LVEF ≥55% measured by Echocardiography (preferred) or MUGA scan
  • Normal hematologic status: Absolute neutrophil count ≥1500/mm3 (1.5 × 109/L); Platelets ≥100 × 109/L; Hemoglobin ≥9 g/dL (≥90 g/L).
  • Normal renal function: serum creatinine ≤1.5 ULN
  • Normal liver function: Serum total bilirubin ≤1.5 × upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 × ULN) is allowed; AST or ALT ≤2.5 × ULN; Alkaline phosphatase ≤2.5 × ULN.
  • Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
  • The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
  • The patient agrees in writing to make tumor (mandatory diagnostic core biopsy and surgical specimen) available for submission for central pathology review and to conduct translational studies as part of this protocol.

Exclusion Criteria:

  • Tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) (T4 according to AJCC 8th edition cancer staging TNM)
  • Inflammatory breast cancer
  • Bilateral invasive breast cancer
  • Received any prior treatment for primary invasive breast cancer
  • Any active tumor of non-breast-cancer histology
  • Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina pectoris, ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA functional classification ≥II), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety
  • Contraindications or known hypersensitivity to any of the trial medications or excipients
  • Treatment with any investigational agents within 30 days prior to expected start of trial treatment
  • Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post major bowel resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644186


Contacts
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Contact: Colleen King +17168340900 ibcsg55_TOUCH@fstrf.org

Locations
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Belgium
AZ Klina, Augustijinslei 100 Recruiting
Brasschaat, Belgium, 2930
Contact: Didier Verhoeven, MD    +32 3 650 5157    didier.verhoeven@klina.be   
Principal Investigator: Didier Verhoeven, MD         
Jules Bordet Institute Recruiting
Brussels, Belgium, 1000
Contact: Andrea Gombos, MD    +32 2 541 7232    andrea.gombos@bordet.be   
Principal Investigator: Andrea Gombos, MD         
CHR de la Citadelle, Boulevard du XIIe de Ligne, 1 Not yet recruiting
Liège, Belgium, 4000
Contact: Jean P Salmon, MD    +32 4 321 6445    jean.paul.salmon@chrcitadelle.be   
Principal Investigator: Jean P Salmon, MD         
Clinique Saint- Joseph, Rue de Hesbaye 75 Not yet recruiting
Liège, Belgium, 4000
Contact: Marie Pascale, MD    +32 3 224 8990    marie-pascale.graas@chc.be   
Principal Investigator: Marie Pascale, MD         
Clinique Saint Elizabeth, Place Louise Godin 15 Recruiting
Namur, Belgium, 5000
Contact: Donatienne Taylor, MD    +32 81 720 524    donatienne.taylor@uclouvain.be   
Principal Investigator: Donatienne Taylor, MD         
AZ Nikolaas, Moerlandstrat 1 Not yet recruiting
Sint-Niklaas, Belgium, 9100
Contact: Ines Deleu, MD    +32 3 760 2975    ines.deleu@aznikolaas.be   
Contact: Ines Deleu         
Principal Investigator: Ines Deleu, MD         
Italy
Clinica Oncologica-Ospedali Riuniti Ancona, Via Conca n.71, Not yet recruiting
Torrette, Ancona, Italy, 60020
Contact: R Berardi, MD    +390 71596 5715    r.berardi@univpm.it   
Principal Investigator: R Berardi, MD         
Istituto scientifico Romagnolo per lo studio e la cura,Via Piero Maroncelli 40 Not yet recruiting
Meldola, Forli, Italy, 47014
Contact: Andrea Rocca, MD    +390 543 739 100    andrea.rocca@irst.emr.it   
Principal Investigator: Andrea Rocca, MD         
Istituto Clinico Humanitas, Via Manzoni 56 Not yet recruiting
Rozzano, Milano, Italy, 20089
Contact: Giovanna Masci, MD    +390 2 8224 4671    giovanna.masci@humanitas.it   
Principal Investigator: Giovanna Masci, MD         
U.O Medicina Oncologica Ospedale di Carpi, Via G. Molinari, 2 Not yet recruiting
Carpi, Modena, Italy, 41012
Contact: Fabrizio Artioli, MD    +390 59 659 313    f.artioli@ausl.mo.it   
Principal Investigator: Fabrizio Artioli, MD         
Oncologia Medica Fano Italy,V.le Vittorio Veneto 2 Not yet recruiting
Fano, Pesaro, Italy, 31032
Contact: Rodolfo Mattioli, MD    +390 721 882 239    rodolfomattioli@libero.it   
Principal Investigator: Rodolfo Mattioli, MD         
Centro di Riferimento Oncologico (CRO), Via Franco Gallini 2 Not yet recruiting
Aviano, Pordenone, Italy, 33081
Contact: Centro Spazzapan, MD    +390 434 659 310    spazzapan@cro.it   
Principal Investigator: Centro Spazzapan, MD         
Multimedica Spa, Viale Piemonte 70 Not yet recruiting
Castellanza, Vareze, Italy, 21053
Contact: Luisapaola Molteni, MD    +390 331 393 272    luisapaola.molteni@multimedica.it   
Principal Investigator: Luisapaola Molteni, MD         
ASO "SS Antonio e Biagio Cesare Arrigo, Via Venezia 16 Not yet recruiting
Alessandria, Italy, 15121
Contact: P F Guglielmini, MD    +390 131 206 623    pfguglielmini@ospedale.al.it   
Principal Investigator: P F Guglielmini, MD         
Ospedali Riuniti di Bergamo, A.O.Papa Giovanni XXIII, Piazza OMS1 Not yet recruiting
Bergamo, Italy, 24127
Contact: Carlo Tondini, MD    +390 35 267 3694    carlo.tondini@asst-pg23.it   
Principal Investigator: Carlo Tondini         
Ospedale S. Orsola-Malpighi, Viale Ercolani 4/2 Not yet recruiting
Bologna, Italy, 40138
Contact: Claudio Zamagni, MD    +390 512 144 548    claudio.zamagni@aosp.bo.it   
Principal Investigator: Claudio Zamagni, MD         
Comprensorio Sanitario Bolzano, Via Lorenz Bohler, 5 Recruiting
Bolzano, Italy, 39100
Contact: Elisabetta Cretella, MD    +390 471 908 572    ELISABETTA.CRETELLA@sabes.it   
Principal Investigator: Elisabetta Cretella, MD         
ASST Spedali Civili Brescia, Piazzale Spedali Civili n.1 Not yet recruiting
Brescia, Italy, 25123
Contact: Edda Simoncini, MD    +390 30 399 5260    edda.simoncini@asst-spedalicivili.it   
Principal Investigator: Edda Simoncini         
E.O. Ospedali Galliera, Mura delle Cappuccine, 14 Not yet recruiting
Genova, Italy, 16128
Contact: Mauro D'Amico, MD    +390 105 634 506    mauro.damico@galliera.it   
Principal Investigator: Mauro D'Amico, MD         
Ospedale Policlinico San Martino,Largo Rosanna Benzi,10 Not yet recruiting
Genova, Italy, 16132
Contact: Lucia Del Mastro, MD    +390 10 555 8908    lucia.delmastro@hsanmartino.it   
Principal Investigator: Lucia Del Mastro, MD         
Ospedale Civile di Lecco,Via della Filanda 14 Not yet recruiting
Lecco, Italy, 23900
Contact: Azienda O Ardizzoia, MD    +390341489900    a.ardizzoia@asst-lecco.it   
Principal Investigator: Azienda Ardizzoia, MD         
Milano, IEO, Via Ripamonti 435 Recruiting
Milano, Italy, 20141
Contact: Marco Colleoni, MD    +390 257 489 934    marco.colleoni@ieo.it   
Principal Investigator: Marco Colleoni, MD         
Università del Piemonte Orientale - SCDU Oncologia, Corso Mazzini 18 Not yet recruiting
Novara, Italy, 28100
Contact: Alessandra Gennari, MD    +390 321 373 3984    alessandra.gennari@med.uniupo.it   
Principal Investigator: Alessandra Gennari, MD         
Azienda Ospedaliero-Universitaria di Parma, via Gramsci 14 Not yet recruiting
Parma, Italy, 43126
Contact: Azienda Musolino, MD    +39 0521702316    amusolino@ao.pr.it   
Principal Investigator: Azienda Musolino, MD         
Istituti Clinici Scientifici Maugeri SpA-SB,Via Salvatore Maugeri N° 10 Recruiting
Pavia, Italy, 27100
Contact: Antonio Bernardo, MD    +390 38 259 2669    antonio.bernardo@icsmaugeri.it   
Principal Investigator: Antonio Bernardo, MD         
A.O. Universitaria Pisana Ospedale Santa Chiara Pisa, Via Roma 67 Not yet recruiting
Pisa, Italy, 56125
Contact: A Fontana, MD    +390 50 992 466    an.fontana@ao-pisa.toscana.it   
Principal Investigator: A Fontana, MD         
Hospital of Prato, Via Dolce dei Mazzamuti, 7 Not yet recruiting
Prato, Italy, 59100
Contact: Laura Biganzoli, MD    +390 574 802 531    laura.biganzoli@uslcentro.toscana.it   
Principal Investigator: Laura Biganzoli, MD         
Santa Maria delle Croci Hospital, Viale Randi 5 Not yet recruiting
Ravenna, Italy, 48121
Contact: Laura Amaducci, MD    +390 54 660 1196    laura.amaducci@auslromagna.it   
Principal Investigator: Laura Amaducci, MD         
UO Oncologia, Rimini Hospital, Via Settembrini 2 Not yet recruiting
Rimini, Italy, 47037
Contact: Lorenzo Gianni, MD    +390 541 705 413    lorenzo.gianni@auslromagna.it   
Principal Investigator: Lorenzo Gianni, MD         
Azienda Ospedaliero-Universitaria di Udine, Piazzale S.M. Misericordia 15 Recruiting
Udine, Italy, 33100
Contact: Alessandro Minisini, MD    +390 432 552 754    alessandro.minisini@asuiud.sanita.fvg.it   
Principal Investigator: Alessandro Minisini, MD         
AO Universitaria Ospedale Di Circolo e Fondazione,v.le L. Borri, 57 Not yet recruiting
Varese, Italy, 21100
Contact: Graziella Pinotti, MD    +390 33 227 8558    graziella.pinotti@asst-settelaghi.it   
Principal Investigator: Graziella Pinotti, MD         
Switzerland
Kantonsspital Baden AG Recruiting
Baden, Aarau, Switzerland, 5400
Contact: Cornelia Leo, MD       Cornelia.Leo@ksb.ch   
Principal Investigator: Cornelia Leo, MD         
Universitatsspital Basel, Petersgraben 4 Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Marcus Vetter, MD    +41 61 265 5074    marcus.vetter@usb.ch   
Principal Investigator: marcus Vetter, MD         
Brustzentrum Thurgau / Kantonsspital Frauenfeld, Pfaffenholzstrasse 4 Recruiting
Frauenfeld, Thurgau, Switzerland, 8501
Contact: Mathias Fehr, MD    +41 52 723 7255    mathias.fehr@stgag.ch   
Principal Investigator: Mathias Fehr         
Oncology Institute of Southern Switzerland (IOSI), Ospedale San Giovanni, IOSI Recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact: Olivia Pagani, MD    +41 79 208 7785    olivia.pagani@eoc.ch   
Principal Investigator: Olivia Pagani         
University Hospital Zurich, Frauenklinikstrasse 10 Not yet recruiting
Zürich, Zurich, Switzerland, 8091
Contact: Konstantin Dedes, MD    +41 44 255 5200    konstantin.dedes@usz.ch   
Principal Investigator: Konstantin Dedes, MD         
Kantonsspital Winterthur Recruiting
Winterthur, Zürich, Switzerland, 8401
Contact: Andreas Mueller, MD       andreas.mueller@ksw.ch   
Principal Investigator: Andreas Mueller, MD         
University Hospital Geneva Recruiting
Geneva, Switzerland
Contact: Bodmer Alexandre       Alexandre.Bodmer@hcuge.ch   
Principal Investigator: Alexandre Bodmer         
Kantonsspital St. Gallen, Rorschacher Strasse 95 Recruiting
Saint Gallen, Switzerland, 9007
Contact: Patrik S Weder, MD    '+41 71 494 1111    patrik.weder@kssg.ch   
Principal Investigator: Patrik Weder, MD         
Brust-Zentrum AG, Seefeldstrasse 214 Recruiting
Zurich, Switzerland, 8008
Contact: Urs Breitenstein, MD    +41 44 380 7660    urs.breitenstein@ozh.ch   
Principal Investigator: Urs Breitenstein, MD         
Sponsors and Collaborators
International Breast Cancer Study Group
Pfizer
Hoffmann-La Roche
Investigators
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Study Chair: Laura Biganzoli, MD USL4 Hospital of Prato, Italy
Study Chair: Etienne Brain, MD Institut Curie, Paris, France

Publications:

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Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT03644186     History of Changes
Other Study ID Numbers: IBCSG 55-17
2017-005067-40 ( EudraCT Number )
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by International Breast Cancer Study Group:
hormone receptor positive early breast cancer
HER2 receptor positive early breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Letrozole
Palbociclib
Pertuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors