Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)
NCT02605486
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
646-888-4536
A patient will be eligible for androgen receptor expression testing (STEP 1) if the following criteria are met:
- Female
- Pathologically confirmed invasive cancer of the breast
- ER/PR status (ER or PR defined as positive if ≥1%; ER/PR is defined as negative if <1%):
- Phase I: Patients may have ER/PR(-) breast cancer.
- HER2 normal (IHC 0-1; FISH < 2.0)
- Non-measurable or measurable, metastatic disease
- Available tissue for AR testing for research purposes
A patient will be eligible for participation in the therapeutic trial (STEP 2) if the following criteria are met:
- Androgen receptor expression testing confirms that the patient's tumor is AR (+). AR is considered positive if ≥1% of cell nuclei are immunoreactive using the Dako antibody (clone AR441). Receptor testing may be performed on either primary tumor specimen or tissue from a metastatic site. Local testing permitted for eligibility but will require confirmation at MSKCC.
- There is no limit to the number of prior chemotherapy or endocrine therapy regimens allowed. Patients with ER(+) AR(+) breast cancer must have had at least 1 prior line of endocrine therapy to be eligible for the phase I portion of the trial.
- At least 2 weeks since last cytotoxic chemotherapy, hormonal therapy, or radiotherapy. Toxicities related to prior therapy must either have returned to grade 1, or baseline (excluding alopecia)
- Patient may receive bisphosphonates/denosumab for the palliation of bone metastases
- If patient has a history of brain metastases or leptomeningeal disease, lesions must be stable for at least 3 months (as documented by either head CT or brain MRI)
- Prior treatment with bicalutamide will not be allowed
- At least 3 weeks from major surgery with full recovery
- ECOG performance status 0-2
- Age 18 years or greater
- Postmenopausal. Use of LHRH agonist permitted.
- Patients must not have another, non-breast, active malignancy that requires treatment.
- The effects of palbociclib on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence). Women must not breast feed while on study.
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to swallow intact palbociclib capsules and bicalutamide tablets.
- Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):
- Absolute neutrophil count ≥ 1.5 10^9/
- Hemoglobin ≥ 9.0 g/dL
- WBC ≥ 3.0 10^9/L
- Platelets ≥ 100 10^9/L
- Total bilirubin ≤ 1.5 ULN except for patients with known Gilbert syndrome
- AST(SGOT)/ALT(SGPT) ≤ 3 institutional ULN
- Plasma creatinine ≤ 1.5 ULN or Creatinine Clearance > 50 mL/min (calculated by Cockcroft-Gault method)
- QTc interval ≤ 470 msec
- Patients who have not recovered from adverse events of prior therapy to ≤ NCI
CTCAEv4.0 Grade 1.
- Patients receiving any other investigational anti-cancer agents.
- Patients who have received prior treatment with a selective CDK4/6 inhibitor
- Patients who have received prior anti-androgen therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to palbociclib.
- Uncontrolled intercurrent illness including, but not limited to, known ongoing or
active infection, including HIV, active hepatitis B or C, symptomatic congestive heart
failure, unstable angina pectoris, cardiac arrhythmia (specifically, uncontrolled
atrial fibrillation or ventricular dysrhythmias except ventricular premature
contractions), or psychiatric illness/social situations that would limit compliance
with study requirements.
- Pregnant women and women who are breast-feeding.
- Patients with a history of long-QT syndrome or documented family history of long-QT
syndrome. Patients who must remain on drugs that prolong the QT interval.
- Palbociclib is a substrate of CYP3A. Caution should be exercised when dosing
palbociclib concurrently with CYP3A inducers or inhibitors. Furthermore, patients who
are taking concurrent medications that are strong inducers/inhibitors or substrates of
CYP3A4 should be switched to alternative medications to minimize any potential risk.
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Descriptive Information | ||||
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Brief Title ICMJE | Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) | |||
Official Title ICMJE | Phase I/II Trial of Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) | |||
Brief Summary | The purpose of this study is to test the safety and effectiveness of the investigational drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor positive breast cancer. | |||
Detailed Description | The study therapy is to be self administered on an outpatient basis. Patients who meet eligibility criteria and sign informed consent to Step 2 may begin treatment on study. Treatment consists of bicalutamide orally once daily and palbociclib will be given orally daily for 3 weeks on followed by 1 week off. A treatment cycle is considered to be 4 weeks. Eligible patients will be evaluated for toxicity every 2 weeks during Cycle #1 and 2, followed by every 4 weeks in subsequent cycles. Toxicity assessment will include history, physical examination including vital signs, and laboratories including complete blood count and comprehensive metabolic panel. Patients will keep a drug diary to document adherence to oral therapy. Radiographic response evaluation per RECIST will occur every 8 weeks (2 cycles) for cycles 1-6 and then every 12 weeks thereafter with high-resolution CT scan. Patients with suspected bone-only lesions must have bone lesions assessed by CT with bone windows or by bone scan at screening. Phase I: We will use a standard 3+3 design for the dose finding lead in to establish the recommended phase II doses for the combination of palbociclib and bicalutamide. The doses for Phase I will be determined based on the dose level to which the patient is accrued. Phase II: Treatment consists of bicalutamide orally once daily and palbociclib will be given orally daily for 3 weeks on followed by 1 week off at the doses determined in phase I. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Metastatic Breast Cancer (MBC) | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Palbociclib in Combination with Bicalutamide
This is a non-randomized, open-label, phase I/II trial for patients with AR(+) MBC . There will be a dose finding phase I portion of the study to establish the recommended phase II dose (R2PD). This will be followed by a phase II where efficacy is evaluated. Patients with AR(+)ER(-) breast cancer treated on the phase I at the recommended phase II dose will be counted towards the primary endpoint analysis for the phase II study. Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE | 46 | |||
Original Estimated Enrollment ICMJE | 51 | |||
Estimated Study Completion Date ICMJE | November 2022 | |||
Estimated Primary Completion Date | November 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: A patient will be eligible for androgen receptor expression testing (STEP 1) if the following criteria are met:
A patient will be eligible for participation in the therapeutic trial (STEP 2) if the following criteria are met:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02605486 | |||
Other Study ID Numbers ICMJE | 15-207 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Memorial Sloan Kettering Cancer Center | |||
Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | |||
Verification Date | October 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |