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Chemo-Free hope: pill combo aims to shrink HER2+ breast tumors

NCT ID NCT03644186

Disease control Sponsor: ETOP IBCSG Partners Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This phase II trial is testing whether a combination of palbociclib (a targeted pill), hormone therapy, and HER2-targeted drugs can shrink early-stage breast tumors as effectively as standard chemotherapy before surgery. Postmenopausal women with hormone receptor-positive, HER2-positive early breast cancer are randomly assigned to receive either the pill-based regimen or paclitaxel plus HER2 blockade. The main goal is to see if the experimental combo leads to a complete disappearance of invasive cancer at the time of surgery, potentially offering a less toxic alternative to chemo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
palbociclib (a CDK inhibitor) combined with hormonal therapy (letrozole) and HER2 blockade (trastuzumab and pertuzumab), compared with paclitaxel (chemotherapy) plus HER2 blockade
What this could lead to
If successful, this could offer a chemotherapy-free option before surgery for postmenopausal women with hormone receptor-positive, HER2-positive early breast cancer, potentially reducing side effects while achieving similar tumor shrinkage.
What could go wrong
This is a phase II trial, so results are preliminary and may not confirm superiority. Palbociclib combined with hormonal therapy may be less effective than chemotherapy in some patients, and side effects like low blood counts or liver issues could occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

147 people

The number who actually took part.

Started

Apr 2019

Finished

Apr 2023

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 (via physical and/or radiological exam) (cN0) OR * Clinical evidence of cN1 status, defined by nodal involvement limited to clinically or radiologically detectable metastasis to movable ipsilateral level I, II axillary lymph node(s) * No evidence of metastasis (M0). 2. Postmenopausal, defined by women with: * Prior bilateral surgical oophorectomy; OR * Amenorrhea and age ≥60 years; OR * Age \<60 years and amenorrhea for 12 or more consecutive months in the absence of alternative pathological or physiological cause (including chemotherapy, tamoxifen, toremifene, ovarian suppression, or hormonally-based contraception) plus FSH and serum estradiol levels within the laboratory's reference ranges for postmenopausal women 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Primary tumor must have positive estrogen receptor (ER) ≥10% 5. Primary tumor must be HER2-positive (by IHC and/or ISH) 6. Baseline LVEF ≥55% measured by Echocardiography (preferred) or MUGA scan 7. Normal hematologic status: * Absolute neutrophil count ≥1500/mm3 (1.5 × 109/L); * Platelets ≥100 × 109/L; * Hemoglobin ≥9 g/dL (≥90 g/L). 8. Normal renal function: serum creatinine ≤1.5 ULN 9. 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. 10. Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization. 11. The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines. 12. 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: 1. 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) 2. Inflammatory breast cancer 3. Bilateral invasive breast cancer 4. Received any prior treatment for primary invasive breast cancer 5. Any active tumor of non-breast-cancer histology 6. 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. 7. 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 8. Contraindications or known hypersensitivity to any of the trial medications or excipients 9. Treatment with any investigational agents within 30 days prior to expected start of trial treatment 10. Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post major bowel resection 11. Evidence via physical and/or radiological exam of cN2 or cN3 nodal involvement defined by: metastasis to ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted, OR involvement of ipsilateral infraclavicular, internal mammary and/or supraclavicular lymph node(s) 12. History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. A history of prior radiation pneumonitis is not considered an exclusion criterion.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer HER2 positive breast carcinoma triple-positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Estrogen receptor positive tumor HER2-positive breast cancer

Contacts and locations

Locations

  • A.O. Universitaria Pisana Ospedale Santa Chiara Pisa, Via Roma 67

    Pisa, Pisa, 56125, Italy

  • AO Universitaria Ospedale Di Circolo e Fondazione,v.le L. Borri, 57

    Varese, Varese, 21100, Italy

  • ASO "SS Antonio e Biagio Cesare Arrigo, Via Venezia 16

    Alessandria, Alessandria, 15121, Italy

  • ASST Spedali Civili Brescia, Piazzale Spedali Civili n.1

    Brescia, Brescia, 25123, Italy

  • AZ Klina, Augustijinslei 100

    Brasschaat, 2930, Belgium

  • AZ Nikolaas, Moerlandstrat 1

    Sint-Niklaas, 9100, Belgium

  • Azienda Ospedaliero-Universitaria di Parma, via Gramsci 14

    Parma, Parma, 43126, Italy

  • Azienda Ospedaliero-Universitaria di Udine, Piazzale S.M. Misericordia 15

    Udine, Udine, 33100, Italy

  • Brust-Zentrum AG, Seefeldstrasse 214

    Zurich, Canton of Zurich, 8008, Switzerland

  • Brustzentrum Thurgau / Kantonsspital Frauenfeld, Pfaffenholzstrasse 4

    Frauenfeld, Thurgau, 8501, Switzerland

  • CHR de la Citadelle, Boulevard du XIIe de Ligne, 1

    Liège, 4000, Belgium

  • Centre Antoine Lacassagne

    Nice, France

  • Centre Eugène Marquis

    Rennes, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Annecy Genevois

    Pringy, France

  • Centre Hospitalier Le Mans

    Le Mans, France

  • Centre Léon Berard

    Lyon, France

  • Centro di Riferimento Oncologico (CRO), Via Franco Gallini 2

    Aviano, Pordenone, 33081, Italy

  • Clinica Oncologica-Ospedali Riuniti Ancona, Via Conca n.71,

    Torrette, Ancona, 60020, Italy

  • Clinique Pasteur

    Toulouse, France

  • Clinique Saint Elizabeth, Place Louise Godin 15

    Namur, 5000, Belgium

  • Clinique Saint- Joseph, Rue de Hesbaye 75

    Liège, 4000, Belgium

  • Comprensorio Sanitario Bolzano, Via Lorenz Bohler, 5

    Bolzano, Bolzano, 39100, Italy

  • E.O. Ospedali Galliera, Mura delle Cappuccine, 14

    Genova, Genova, 16128, Italy

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, France

  • HFR Freiburg - Kantonsspital

    Fribourg, 1708, Switzerland

  • Hospital of Prato, Via Dolce dei Mazzamuti, 7

    Prato, Prato, 59100, Italy

  • ICM Val d'Aurelle

    Montpellier, France

  • Inselspital Bern

    Bern, Switzerland

  • Institut Bergonié

    Bordeaux, France

  • Institut Claudius Regaud

    Toulouse, France

  • Institut Curie - Site Saint Cloud

    Saint-Cloud, 92210, France

  • Institut Curie - Site de Paris

    Paris, France

  • Institut Sainte Catherine

    Avignon, France

  • Institut de Cancérologie de l'Ouest (ICO)

    Nantes, France

  • Istituti Clinici Scientifici Maugeri SpA-SB,Via Salvatore Maugeri N° 10

    Pavia, Pavia, 27100, Italy

  • Istituto scientifico Romagnolo per lo studio e la cura,Via Piero Maroncelli 40

    Meldola, Forli, 47014, Italy

  • Jules Bordet Institute

    Brussels, 1000, Belgium

  • Kantonsspital Baden AG

    Baden, Aarau, 5400, Switzerland

  • Kantonsspital St. Gallen, Rorschacher Strasse 95

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Kantonsspital Winterthur

    Winterthur, Canton of Zurich, 8401, Switzerland

  • Milano, IEO, Via Ripamonti 435

    Milan, Milano, 20141, Italy

  • Oncology Institute of Southern Switzerland (IOSI), Ospedale San Giovanni, IOSI

    Bellinzona, Canton Ticino, 6500, Switzerland

  • Ospedale Civile di Lecco,Via della Filanda 14

    Lecco, Lecco, 23900, Italy

  • Ospedale Policlinico San Martino,Largo Rosanna Benzi,10

    Genova, Genova, 16132, Italy

  • Ospedale S. Orsola-Malpighi, Viale Ercolani 4/2

    Bologna, Bologna, 40138, Italy

  • Ospedali Riuniti di Bergamo, A.O.Papa Giovanni XXIII, Piazza OMS1

    Bergamo, Bergamo, 24127, Italy

  • Santa Maria delle Croci Hospital, Viale Randi 5

    Ravenna, Ravenna, 48121, Italy

  • U.O Medicina Oncologica Ospedale di Carpi, Via G. Molinari, 2

    Carpi, Modena, 41012, Italy

  • UO Oncologia, Rimini Hospital, Via Settembrini 2

    Rimini, Rimini, 47037, Italy

  • Universitatsspital Basel, Petersgraben 4

    Basel, Canton of Basel-City, 4031, Switzerland

  • University Hospital Geneva

    Geneva, Switzerland

  • University Hospital Zurich, Frauenklinikstrasse 10

    Zurich, Canton of Zurich, 8091, Switzerland

  • Università del Piemonte Orientale - SCDU Oncologia, Corso Mazzini 18

    Novara, Novara, 28100, Italy

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