61
Participants
Start Date
October 19, 2012
Primary Completion Date
March 4, 2016
Study Completion Date
October 25, 2018
PD-0332991
PD-0332991 (100 mg or 125 mg) will be orally administered once a day for 3 weeks followed by 1 week off treatment, in the morning on an empty stomach. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.
PD-0332991
PD-0332991, 125 mg, will be orally administered with food once a day for 3 weeks followed by 1 week off treatment. PD-0332991 will be administered once a day together with letrozole. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.
letrozole
Letrozole, 2.5 mg, will be orally administered once a day in continuous daily dosing together with PD-0332991. Dose reduction of letrozole is not permitted, but dosing interruptions for letrozole-related toxicity are allowed as per investigator's medical judgement.
PD-0332991
PD-0332991, 125 mg, will be orally administered with food once a day for 3 weeks followed by 1 week off treatment. PD-0332991 will be administered once a day together with letrozole. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.
letrozole
Letrozole, 2.5 mg, will be orally administered once a day in continuous daily dosing together with PD-0332991. Dose reduction of letrozole is not permitted, but dosing interruptions for letrozole-related toxicity are allowed as per investigator's medical judgement.
Aichi Cancer Center Hospital, Nagoya
National Cancer Center Hospital East, Kashiwa
National Hospital Organization Hokkaido Cancer Center, Sapporo
Kumamoto Shinto General Hospital, Kumamoto
Saitama Cancer Center, Kita-adachi-gun
National Cancer Center Hospital, Chuo-Ku
Chiba Cancer Center, Chiba
National Hospital Organization Shikoku Cancer Center, Ehime
National Hospital Organization Kyushu Cancer Center, Fukuoka
Hiroshima City Hiroshima Citizens Hospital, Hiroshima
Hakuaikai Medical Corporation Sagara Hospital, Kagoshima
Kumamoto University Hospital, Kumamoto
Kumamoto City Hospital, Kumamoto
Kyoto University Hospital, Kyoto
Iwate Medical University Hospital, Numakunai
National Hospital Organization Osaka National Hospital, Osaka
Lead Sponsor
Pfizer
INDUSTRY