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POLAR - Studio di fase III in aperto, multicentrico e randomizzato sull'uso di palbociclib adiuvante in combinazione con terapia endocrina rispetto alla sola terapia endocrina in pazienti affetti/e da recidiva loco-regionale isolata positiva per i recettori ormonali / HER2-negativa del carcinoma mammario, già sottoposta a resezione.

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- Histologically confirmed invasive breast cancer, defined as first proven ipsilateral local and/or regional recurrence:
    – Breast
    – Chest wall including mastectomy scar and/or skin
    – Axillary or internal mammary lymph nodes
- Completion of locoreginal therapy:
    – Completion of gross excision of recurrence within 6 months prior to enrolment
    – Completion or radiotherapy (if given) more than 2 weeks prior to enrolment
- Negative or microscopically involved margins
- Female or male aged 18 years or older
- ECOG performance status 0 or 1
- Recurrent tumor must be hormone receptor positive: ER+ and/or PgR+ ≥1%
- Recurrent tumor must be HER2-negative (0, 1+, 2+ by IHC and/or ISH/FISH not amplified)
- Tumor with HER2 status 2+ by IHC must also be negative (not amplified) by ISH
- Normal hematological, renal, and liver function
- The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines
- The patient agrees to make tumor (diagnostic core biopsy or surgical specimen of ILRR) available for submission for central pathology review
- Patients must either be planned to initiate, or have already started, endocrine therapy
- Written Informed Consent (IC) prior to randomization

Criteri di esclusione: 

- Recurrence of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) not surgically removable
- Evidence of distant metastasis as based on conventional staging examinations (physical, chest X-ray or CT, abdominal ultrasound or CT, bone scintigraphy OR FDG-PET-CT).
- Bilateral invasive breast cancer (in situ carcinoma of the other breast is OK)
- Inflammatory breast cancer
- Patients with a malignancy history, other than invasive breast cancer, with the following exceptions:
    – Patients diagnosed and disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence of that malignancy are eligible
    – Patients with the following malignancies are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast; cervical cancer in situ; thyroid cancer in situ; non-metastatic, non-melanomatous skin cancers
- Previous treatment with palbociclib or any other CDK 4/6 inhibitors
- Previous or planned chemotherapy or planned radiotherapy for the ipsilateral local and/or regional recurrence
- 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 the trial medication or excipients
- Pregnant or lactating; lactation has to stop before randomization

Schema di trattamento: 

Arm A:
- Palbociclib 125 mg/day orally for 21 days, followed by 7 days rest for 3 years from randomization.
- Standard endocrine therapy for at least 3 years from randomization

Arm B:
- Standard endocrine therapy for at least 3 years from randomization

Trattamento sperimentale: 

Palbociclib plus standard endocrine therapy

Trattamento di controllo: 

Standard endocrine therapy

Obiettivi primari dello studio: 

To determine whether treatment with 3 years of palbociclib plus endocrine therapy prolongs disease-free survival (iDFS) compared to treatment with endocrine therapy alone in patients with hormone receptor positive, HER2-negative resected isolated locoregional recurrence (ILRR) of breast cancer.

Centri partecipanti

Nord Italia

Ospedale Riuniti
Largo Barozzi 1 - 24128 Bergamo - BG

 

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Andrea Rocca
Email: andrea.rocca@irst.emr.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Dr.ssa Elisabetta Munzone
Telefono: 0257489502
Email: elisabetta.munzone@ieo.it

 

A.O.U. “ Maggiore della Carità”
Corso Mazzini 18 - 28100 Novara - NO
Università del Piemonte Orientale - SCDU Oncologia

Riferimento: Prof.ssa Alessandra Gennari

 

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR

Riferimento: Dr. Antonino Musolino
Email: amusolino@ao.pr.it

 

Fondazione Salvatore Maugeri-IRCCS
Via Salvatore Maugeri 4 - 27100 Pavia - PV

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN

Riferimento: Dr. Simon Spazzapan
Email: Ricerca.omp@cro.it

 

Ospedale “Infermi” Rimini
Via Settembrini 2 - 47923 Rimini - RN
UO Oncologia

 

Centro Italia

Nuovo Ospedale di Prato
Via Suor Niccolina Infermiera 20 - 59100 Prato - PO

Riferimento: Dr.ssa Laura Biganzoli
Email: laura.biganzoli@uslcentro.toscana.it

 

Sud Italia e isole

Ospedale Senatore Antonio Perrino
St.Statale 7 per Mesagne - 72100 Brindisi - BR
UOC Oncologia Medica

Riferimento: Prof. Saverio Cinieri
Email: saverio.cinieri@ieo.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-003553-19

Data di inserimento: 06.07.2020

Promotore

International Breast Cancer Study Group (IBCSG)

CRO

/

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Dr.ssa Elisabetta Munzone

Telefono: 0257489502

Email: elisabetta.munzone@ieo.it

Localita: Milano

 

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