Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
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ClinicalTrials.gov Identifier: NCT01942135 |
Recruitment Status :
Completed
First Posted : September 13, 2013
Results First Posted : May 23, 2016
Last Update Posted : April 4, 2024
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Sponsor:
Pfizer
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Metastatic Breast Cancer |
Interventions |
Drug: Palbociclib Drug: Fulvestrant Drug: Placebo |
Enrollment | 521 |
Participant Flow
Recruitment Details | The study was conducted at 144 sites in 17 countries that randomized 521 participants. Eligible participants were to have histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of recurrent (local or metastatic) disease. |
Pre-assignment Details | The study consisted of a screening visit within 28 days before randomization, an active treatment phase, divided in cycles of 28 days each, and a post-treatment follow-up period during which survival and new anti-cancer therapy information was collected every 3 months for the first 9 months, then every 6 months from the last dose of study intervention. |
Arm/Group Title | Palbociclib + Fulvestrant | Placebo + Fulvestrant |
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Arm/Group Description | Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles. | Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles. |
Period Title: Overall Study | ||
Started | 347 | 174 |
Treated | 345 | 172 |
Completed | 0 | 0 |
Not Completed | 347 | 174 |
Reason Not Completed | ||
Adverse Event | 21 | 7 |
Global Deterioration of Health Status | 9 | 6 |
Randomized Not Treated | 2 | 2 |
Death | 2 | 1 |
Objective Progression or Relapse + Progressive Disease | 279 | 148 |
Participant Refused to Continue Treatment for Reason Other than Adverse Event | 10 | 3 |
Withdrawal by Subject | 4 | 3 |
Protocol Violation | 1 | 0 |
Other | 19 | 4 |
Baseline Characteristics
Arm/Group Title | Palbociclib + Fulvestrant | Placebo + Fulvestrant | Total | |
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Arm/Group Description | Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles. | Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles. | Total of all reporting groups | |
Overall Number of Baseline Participants | 347 | 174 | 521 | |
Baseline Analysis Population Description |
The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study intervention assignment designated according to initial randomization, regardless of whether participants received study intervention or received a different drug from that to which they were randomized.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 347 participants | 174 participants | 521 participants | |
56.9 (11.7) | 56.8 (10.4) | 56.9 (11.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 347 participants | 174 participants | 521 participants | |
Female |
347 100.0%
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174 100.0%
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521 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 347 participants | 174 participants | 521 participants | |
Hispanic or Latino |
17 4.9%
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11 6.3%
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28 5.4%
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Not Hispanic or Latino |
329 94.8%
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161 92.5%
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490 94.0%
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Unknown or Not Reported |
1 0.3%
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2 1.1%
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3 0.6%
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Menopausal Status
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 347 participants | 174 participants | 521 participants | |
Postmenopausal |
275 79.3%
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138 79.3%
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413 79.3%
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Pre/Perimenopausal |
72 20.7%
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36 20.7%
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108 20.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01942135 |
Other Study ID Numbers: |
A5481023 2013-002580-26 ( EudraCT Number ) |
First Submitted: | September 10, 2013 |
First Posted: | September 13, 2013 |
Results First Submitted: | December 3, 2015 |
Results First Posted: | May 23, 2016 |
Last Update Posted: | April 4, 2024 |