Clinical trial • Phase III • Oncology
Palbociclib for Breast cancer | Hormone receptor positive breast cancer | HER2-negative breast cancer | Locoregional recurrence of breast cancer
Phase III trial of Palbociclib for Breast cancer | Hormone receptor positive breast cancer | HER2-negative breast cancer | Locoregional recurrence of brea…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer | Hormone receptor positive breast cancer | HER2-negative breast cancer | Locoregional recurrence of breast cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 19-02-2024
- First CTIS Authorization Date
- 04-04-2024
Trial design
Randomised, open-label, 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-controlled Phase III trial in Hungary, Austria, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- 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
- Target Sample Size
- 381
- Trial Duration For Participant
- 1095
Eligibility
Recruits 381 Vulnerable population selected. Written Informed Consent (IC) is required from each participant prior to randomization. Country-specific subject information sheets and informed consent forms (SIS/ICF) and addenda are provided (including versions for pregnant partner and Women of Childbearing potential) for participating countries. No procedures for assent of minors are described (participants must be 18 years or older)..
- Pregnancy Exclusion
- Pregnant or lactating women; lactation has to stop before randomization
- Vulnerable Population
- Vulnerable population selected. Written Informed Consent (IC) is required from each participant prior to randomization. Country-specific subject information sheets and informed consent forms (SIS/ICF) and addenda are provided (including versions for pregnant partner and Women of Childbearing potential) for participating countries. No procedures for assent of minors are described (participants must be 18 years or older).
Inclusion criteria
- {"criterion_text":"- Histologically confirmed invasive breast cancer, defined as first proven ipsilateral local and/or regional recurrence of a primary invasive breast cancer in at least one of the sites below: – Breast – Chest wall including mastectomy scar and/or skin – Axillary or internal mammary lymph nodes\n- Completion of locoregional therapy: – Completion of gross excision of recurrence within 6 months prior to randomization – Completion of radiotherapy (if given) more than 2 weeks prior to randomization\n- Negative or microscopically involved margins\n- Female or male aged 18 years or older\n- ECOG performance status 0 or 1\n- Recurrent tumor must be hormone receptor positive: ER+ and/or PgR+ ≥1% by IHC\n- 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/FISH\n- Normal hematological, renal, and liver function\n- The patient agrees to make tumor (diagnostic core biopsy or surgical specimen of ILRR) available for submission for central pathology review\n- Patients must either be planned to initiate, or have already started, endocrine therapy for ipsilateral isolated locoregional recurrence\n- Written Informed Consent (IC) prior to randomization"}
Exclusion criteria
- {"criterion_text":"- Recurrence of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) not surgically removable\n- 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).\n- Bilateral synchronous or metachronous invasive breast cancer (in situ carcinoma of the contralateral breast is allowed)\n- Inflammatory breast cancer\n- Patients with a history of malignancy, other than invasive breast cancer, with the following exceptions: – Patients diagnosed, treated 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\n- Previous treatment with palbociclib or any other CDK 4/6 inhibitors\n- Previous or planned chemotherapy or planned radiotherapy for the ipsilateral isolated locoregional recurrence (radiotherapy is allowed, but must be completed more than 2 weeks prior to randomization)\n- Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient’s safety\n- Contraindications or known hypersensitivity to the palbociclib or excipients\n- 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. History of prior radiation pneumonitis is not an exclusion criterion.\n- Pregnant or lactating women; lactation has to stop before randomization"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint iDFS is defined as duration of time from randomization until first appearance of invasive local, regional, or distant recurrence (including invasive ipsilateral breast tumor recurrence), invasive contralateral breast cancer, a second (non-breast) invasive cancer, or death from any cause.","definition_or_measurement_approach":"iDFS is defined as duration of time from randomization until first appearance of invasive local, regional, or distant recurrence (including invasive ipsilateral breast tumor recurrence), invasive contralateral breast cancer, a second (non-breast) invasive cancer, or death from any cause."}
Secondary endpoints
- {"endpoint_text":"- Adverse events, according to CTCAE version 5\n- Breast cancer-free interval (BCFI)\n- Distant recurrence-free interval (DRFI)\n- Overall survival (OS)","definition_or_measurement_approach":"Adverse events: graded according to CTCAE version 5. BCFI, DRFI and OS are listed as time-to-event endpoints (definitions not further specified in the available text)."}
Recruitment
- Planned Sample Size
- 381
- Recruitment Window Months
- 90
- Consent Approach
- Written Informed Consent (IC) required prior to randomization. Country-specific subject information sheets and ICFs are provided in multiple language versions and with addenda (including pregnant partner and Women of Childbearing potential versions). Consent is obtained from the participant; no assent for minors is described as minimum age is 18 years.
Geography
- Total Number Of Sites
- 38
- Total Number Of Participants
- 381
Hungary
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 05-05-2025
- Processing Time Days
- 431
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- National Institute of Oncology
- Department Name
- Medical oncology
- Principal Investigator Name
- Gabor Rubovszky
- Principal Investigator Email
- garub@oncol.hu
- Contact Person Name
- Gabor Rubovszky
- Contact Person Email
- garub@oncol.hu
- Number Of Participants
- 30
Austria
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 31-03-2025
- Processing Time Days
- 396
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Medical University Of Graz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Christoph Suppan
- Principal Investigator Email
- christoph.suppan@medunigraz.at
- Contact Person Name
- Christoph Suppan
- Contact Person Email
- christoph.suppan@medunigraz.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Medical oncology
- Principal Investigator Name
- Daniel Egle
- Principal Investigator Email
- daniel.egle@tirol-kliniken.at
- Contact Person Name
- Daniel Egle
- Contact Person Email
- daniel.egle@tirol-kliniken.at
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Simon Peter Gampenrieder
- Principal Investigator Email
- s.gampenrieder@salk.at
- Contact Person Name
- Simon Peter Gampenrieder
- Contact Person Email
- s.gampenrieder@salk.at
Spain
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 07-05-2025
- Processing Time Days
- 433
- Number Of Sites
- 13
- Number Of Participants
- 141
Sites
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jose Ponce Lorenzo
- Principal Investigator Email
- JOSEPONCE.ONCOALICANTE@GMAIL.COM
- Contact Person Name
- Jose Ponce Lorenzo
- Contact Person Email
- JOSEPONCE.ONCOALICANTE@GMAIL.COM
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Medical Oncology
- Principal Investigator Name
- Esteban Nogales Fernández
- Principal Investigator Email
- esteban.nogales@gmail.com
- Contact Person Name
- Esteban Nogales Fernández
- Contact Person Email
- esteban.nogales@gmail.com
- Site Name
- Institut Catala D'oncologia (L'Hospitalet De Llobregat)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Rafael Villanueva Vazquez
- Principal Investigator Email
- ravillanueva@iconcologia.net
- Contact Person Name
- Rafael Villanueva Vazquez
- Contact Person Email
- ravillanueva@iconcologia.net
- Site Name
- Hospital Universitario Basurto
- Department Name
- Medical Oncology
- Principal Investigator Name
- Elena Gleve Calvo
- Principal Investigator Email
- ELENA.GALVECALVO@OSAKIDETZA.EUS
- Contact Person Name
- Elena Gleve Calvo
- Contact Person Email
- ELENA.GALVECALVO@OSAKIDETZA.EUS
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Oncology
- Principal Investigator Name
- Noelia Martinez
- Principal Investigator Email
- mjnoelia@hotmail.com
- Contact Person Name
- Noelia Martinez
- Contact Person Email
- mjnoelia@hotmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Eva Ciruelos
- Principal Investigator Email
- eva.ciruelos@gmail.com
- Contact Person Name
- Eva Ciruelos
- Contact Person Email
- eva.ciruelos@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Meritxell Bellet
- Principal Investigator Email
- mbellet@vhio.net
- Contact Person Name
- Meritxell Bellet
- Contact Person Email
- mbellet@vhio.net
- Site Name
- Hospital Universitario De Canarias
- Department Name
- Medical Oncology
- Principal Investigator Name
- Josefina Cruz Jurado
- Principal Investigator Email
- jcruzjurado@gmail.com
- Contact Person Name
- Josefina Cruz Jurado
- Contact Person Email
- jcruzjurado@gmail.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Joaquin Gauila
- Principal Investigator Email
- jogagre@hotmail.com
- Contact Person Name
- Joaquin Gauila
- Contact Person Email
- jogagre@hotmail.com
- Site Name
- Institut Catala D'oncologia (Girona)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sonia del Barco Berrón
- Principal Investigator Email
- sdelbarco@iconcologia.net
- Contact Person Name
- Sonia del Barco Berrón
- Contact Person Email
- sdelbarco@iconcologia.net
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antonino Anton
- Principal Investigator Email
- aantont@gmail.com
- Contact Person Name
- Antonino Anton
- Contact Person Email
- aantont@gmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Medical Oncology
- Principal Investigator Name
- María Eva Pérez López
- Principal Investigator Email
- MARIA.EVA.PEREZ.LOPEZ@sergas.es
- Contact Person Name
- María Eva Pérez López
- Contact Person Email
- MARIA.EVA.PEREZ.LOPEZ@sergas.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Medical Oncology
- Principal Investigator Name
- Nuria Ribelles
- Principal Investigator Email
- nuriaribelles@gmail.com
- Contact Person Name
- Nuria Ribelles
- Contact Person Email
- nuriaribelles@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 24-06-2025
- Processing Time Days
- 481
- Number Of Sites
- 10
- Number Of Participants
- 160
Sites
- Site Name
- Istituti Clinici Scientifici Maugeri (Pavia)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laura Deborah Locati
- Principal Investigator Email
- lauradeborah.locati@icsmaugeri.it
- Contact Person Name
- Laura Deborah Locati
- Contact Person Email
- lauradeborah.locati@icsmaugeri.it
- Site Name
- European Institute Of Oncology S.r.l. (Milan)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Elisabetta Munzone
- Principal Investigator Email
- elisabetta.munzone@ieo.it
- Contact Person Name
- Elisabetta Munzone
- Contact Person Email
- elisabetta.munzone@ieo.it
- Site Name
- Azienda USL Toscana Centro (Prato)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laura Biganzoli
- Principal Investigator Email
- laura.biganzoli@uslcentro.toscana.it
- Contact Person Name
- Laura Biganzoli
- Contact Person Email
- laura.biganzoli@uslcentro.toscana.it
- Site Name
- UOC ONCOLOGIA MEDICA - P.O. "A. PERRINO" (Brindisi)
- Department Name
- Medical oncology
- Principal Investigator Name
- Sverio Cinieri
- Principal Investigator Email
- saverio.cinieri@ieo.it
- Contact Person Name
- Sverio Cinieri
- Contact Person Email
- saverio.cinieri@ieo.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- Medical Oncology
- Principal Investigator Name
- Simon Spazzapan
- Principal Investigator Email
- spazzapan@cro.it
- Contact Person Name
- Simon Spazzapan
- Contact Person Email
- spazzapan@cro.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna (Rimini)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Lorenzo Gianni
- Principal Investigator Email
- lorenzo.gianni@auslromagna.it
- Contact Person Name
- Lorenzo Gianni
- Contact Person Email
- lorenzo.gianni@auslromagna.it
- Site Name
- Osppedali Riuniti di Bergamo
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alberto Zambelli
- Principal Investigator Email
- azambelli@asst-pg23.it
- Contact Person Name
- Alberto Zambelli
- Contact Person Email
- azambelli@asst-pg23.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. (Meldola)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Samanta Sarti
- Principal Investigator Email
- samanta.sarti@irst.emr.it
- Contact Person Name
- Samanta Sarti
- Contact Person Email
- samanta.sarti@irst.emr.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita (Novara)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alessandra Gennari
- Principal Investigator Email
- alessandra.gennari@maggioreosp.novara.it
- Contact Person Name
- Alessandra Gennari
- Contact Person Email
- alessandra.gennari@maggioreosp.novara.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- Medical Oncology
- Principal Investigator Name
- Daniela Boggiani
- Principal Investigator Email
- Boggiani@ao.pr.it
- Contact Person Name
- Daniela Boggiani
- Contact Person Email
- Boggiani@ao.pr.it
France
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 18-08-2025
- Processing Time Days
- 536
- Number Of Sites
- 11
- Number Of Participants
- 30
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Principal Investigator Name
- Barbara Pistilli
- Principal Investigator Email
- BARBARA.PISTILLI@gustaveroussy.fr
- Contact Person Name
- Barbara Pistilli
- Contact Person Email
- BARBARA.PISTILLI@gustaveroussy.fr
- Site Name
- Groupe Hospitalier Bretagne Sud (Lorient)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Edwina Girard
- Principal Investigator Email
- e.girard@ghbs.bzh
- Contact Person Name
- Edwina Girard
- Contact Person Email
- e.girard@ghbs.bzh
- Site Name
- Polyclinique Bordeaux Nord Aquitaine
- Department Name
- Medical Oncology
- Principal Investigator Name
- Nadine Dohollou
- Principal Investigator Email
- n.dohollou@bordeauxnord.com
- Contact Person Name
- Nadine Dohollou
- Contact Person Email
- n.dohollou@bordeauxnord.com
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laurene Venat-Bouvet
- Principal Investigator Email
- laurence.venat-bouvet@chu-limoges.fr
- Contact Person Name
- Laurene Venat-Bouvet
- Contact Person Email
- laurence.venat-bouvet@chu-limoges.fr
- Site Name
- Institut Sainte Catherine (Avignon)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Julien Grenier
- Principal Investigator Email
- j.grenier@isc84.org
- Contact Person Name
- Julien Grenier
- Contact Person Email
- j.grenier@isc84.org
- Site Name
- Centre Leon Berard (Lyon)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Thomas Bachelot
- Principal Investigator Email
- thomas.bachelot@lyon.unicancer.fr
- Contact Person Name
- Thomas Bachelot
- Contact Person Email
- thomas.bachelot@lyon.unicancer.fr
- Site Name
- Institut Bergonie (Bordeaux)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Camille Chakiba-Brugere
- Principal Investigator Email
- c.chakiba@bordeaux.unicancer.fr
- Contact Person Name
- Camille Chakiba-Brugere
- Contact Person Email
- c.chakiba@bordeaux.unicancer.fr
- Site Name
- Centre Francois Baclesse (Caen)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Christelle Levy
- Principal Investigator Email
- c.levy@baclesse.unicancer.fr
- Contact Person Name
- Christelle Levy
- Contact Person Email
- c.levy@baclesse.unicancer.fr
- Site Name
- Centre Antoine Lacassagne (Nice)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jean-Marc Ferrero
- Principal Investigator Email
- jean-marc.ferrero@nice.unicancer.fr
- Contact Person Name
- Jean-Marc Ferrero
- Contact Person Email
- jean-marc.ferrero@nice.unicancer.fr
- Site Name
- Centre Hospitalier De Cholet
- Department Name
- Medical Oncology
- Principal Investigator Name
- Victor Simmet
- Principal Investigator Email
- victor.simmet@gmail.com
- Contact Person Name
- Victor Simmet
- Contact Person Email
- victor.simmet@gmail.com
- Site Name
- Institut De Cancerologie Strasbourg Europe
- Department Name
- Medical Oncology
- Principal Investigator Name
- Thierry Petit
- Principal Investigator Email
- t.petit@icans.eu
- Contact Person Name
- Thierry Petit
- Contact Person Email
- t.petit@icans.eu
Sponsor
Primary sponsor
- Full Name
- ETOP IBCSG Partners Foundation
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Switzerland
Third parties
- {"country":"United States","full_name":"Frontier Science & Technology Research Foundation Inc.","duties_or_roles":"sponsorDuties code 6","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"IBCSG Central Pathology Office and Laboratory at European Institute of Oncology","duties_or_roles":"sponsorDuties code 4","organisation_type":"Health care"}
- {"country":"United States","full_name":"Dana-Farber Cancer Institute Inc.","duties_or_roles":"sponsorDuties code 10","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties code 15; Palbociclib: drug labeling distribution to site","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- IBRANCE 125 mg film-coated tablets
- Active Substance
- Palbociclib
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 125 mg/day orally for 21 days, followed by 7 days rest (per 28-day cycle)
- Dose Levels
- 75 mg; 100 mg; 125 mg
- Frequency
- 21 days on, 7 days off (per 28-day cycle)
- Maximum Dose
- 125 mg/day
- Investigational Product Name
- IBRANCE 100 mg film-coated tablets
- Active Substance
- Palbociclib
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 125 mg/day orally for 21 days, followed by 7 days rest (dose reductions available as per protocol)
- Dose Levels
- 75 mg; 100 mg; 125 mg
- Frequency
- 21 days on, 7 days off (per 28-day cycle)
- Maximum Dose
- 125 mg/day
- Investigational Product Name
- IBRANCE 75 mg film-coated tablets
- Active Substance
- Palbociclib
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 125 mg/day orally for 21 days, followed by 7 days rest (dose reductions available as per protocol)
- Dose Levels
- 75 mg; 100 mg; 125 mg
- Frequency
- 21 days on, 7 days off (per 28-day cycle)
- Maximum Dose
- 125 mg/day
- Investigational Product Name
- IBRANCE 75 mg hard capsules
- Active Substance
- Palbociclib
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 125 mg/day orally for 21 days, followed by 7 days rest (dose reductions available as per protocol)
- Dose Levels
- 75 mg; 100 mg; 125 mg
- Frequency
- 21 days on, 7 days off (per 28-day cycle)
- Maximum Dose
- 125 mg/day
- Investigational Product Name
- IBRANCE 125 mg hard capsules
- Active Substance
- Palbociclib
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 125 mg/day orally for 21 days, followed by 7 days rest (per 28-day cycle)
- Dose Levels
- 75 mg; 100 mg; 125 mg
- Frequency
- 21 days on, 7 days off (per 28-day cycle)
- Maximum Dose
- 125 mg/day
- Investigational Product Name
- IBRANCE 100 mg hard capsules
- Active Substance
- Palbociclib
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 125 mg/day orally for 21 days, followed by 7 days rest (dose reductions available as per protocol)
- Dose Levels
- 75 mg; 100 mg; 125 mg
- Frequency
- 21 days on, 7 days off (per 28-day cycle)
- Maximum Dose
- 125 mg/day
- Combination Treatment
- Yes
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