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Metastatic Breast Cancer (MBC)Phase 1/2NCT02605486

Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)

A Phase 1/2 study testing Palbociclib and Bicalutamide in people with Metastatic Breast Cancer (MBC), run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer (MBC)
What is being tested?
Palbociclib and Bicalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
5 sitesUnited States
Study dates
11 Nov 2015to Nov 2026
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Memorial Sloan Kettering Cancer Center

    Basking Ridge, New Jersey

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: Phase I/II Trial of Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)

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.

Read the 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.

Being tested
Palbociclib, Bicalutamide
Keywords
palbociclib, bicalutamide, AR(+), 15-207
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02605486
Study groupRoleWhat they receive
Palbociclib in Combination with BicalutamideExperimentalThis 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.
Receives: Drug: Palbociclib; Drug: Bicalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recommended phase II dose (RP2D) (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.

    Measured: 1 year

  2. progression free survival (phase II)

    Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v 1.1 criteria.

    Measured: 6 monthis

Secondary outcomes (4)

  1. Objective response rate (CR+PR)

    Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v 1.1 criteria.

    Measured: 1 year

  2. Clinical benefit rate (CBR)

    (CR+PR+SD)

    Measured: ≥24 weeks

  3. Progression-free survival

    Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v 1.1 criteria.

    Measured: 1 year

  4. Safety and Tolerability by assessing the number of subjects with adverse events

    Safety and tolerability will be summarized as per CTCAE version 4 by type and grade, with the maximum grade used as the summary measure per patient across the period of treatment.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2015 (estimated)
  2. Study start11 Nov 2015
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02605486
Sponsor's protocol ID
15-207
Status last verified
Jul 2026
First submitted
12 Nov 2015
Last updated
7 Jul 2026
Results posted
No

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