Patologia: Neoplasie della mammella
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
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.
Ospedale Riuniti
Largo Barozzi 1 - 24128 Bergamo - BG
IRCCS - IRST Meldola Dino Amadori
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
ICS Maugeri Spa-Società benefit
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
Nuovo Ospedale di Prato
Via Suor Niccolina Infermiera 20 - 59100 Prato - PO
Riferimento: Dr.ssa Laura Biganzoli
Email: laura.biganzoli@uslcentro.toscana.it
Ospedale Senatore Antonio Perrino
St.Statale 7 per Mesagne - 72100 Brindisi - BR
UOC Oncologia Medica
Riferimento: Prof. Saverio Cinieri
Email: saverio.cinieri@ieo.it
Numero di iscrizione a registro: 2018-003553-19
Data di inserimento: 06.07.2020
International Breast Cancer Study Group (IBCSG)
/
Istituto Europeo di Oncologia, Milano
Riferimento: Dr.ssa Elisabetta Munzone
Telefono: 0257489502
Email: elisabetta.munzone@ieo.it
Localita: Milano