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Hormone Receptor Positive Malignant Neoplasm of BreastPhase 2NCT02668666

Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

A Phase 2 study testing Palbociclib and Tamoxifen in people with Hormone Receptor Positive Malignant Neoplasm of Breast and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Oana Danciu, MD at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anticancer therapies for their advanced/metastatic disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Palbociclib and Tamoxifen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
7 sitesUnited States
Study dates
1 Feb 2017to 24 Oct 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following applicable inclusion criteria to participate in this study:
  • Male or female ≥ 18 years of age at time of consent. NOTE: Both pre- and post-menopausal women are eligible. Pre-menopausal status is defined as either:
  • Last menstrual period within the last 12 months.
  • In case of therapy-induced amenorrhea, plasma estradiol and /or FSH is in the premenopausal range per local normal range.
  • Locally advanced, locoregionally recurrent, or metastatic disease, not amenable to curative therapy. NOTE: Although not required as a protocol procedure, a patient with a new metastatic lesion should be considered for biopsy whenever possible to reassess ER/PR/HER2 status if clinically indicated. If a biopsy is prospectively done as part of standard of care, the study would like to store samples for correlative research.
  • Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER >1%, PR >1%), HER2 negative breast cancer. NOTE: Subject has HER2-negative breast cancer (based on most recently analyzed biopsy) is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (e.g. FISH, CISH, SISH, DISH, etc.) test is required by local laboratory testing.
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  • Metastatic disease evaluable on imaging studies. Subjects may have measurable disease as per RECIST 1.1 or bone-only disease. NOTE: Bone-only subjects are eligible if their disease can be documented/ evaluated by bone scans, CT or MRI. Their disease will be assessed using MDA criteria. NOTE: Previously irradiated lesions are eligible as a target lesion only if there is documented progression of the lesion after irradiation.
  • No prior systemic anti-cancer therapy for advanced HR+ disease. NOTE: Subjects receiving adjuvant treatment with aromatase inhibitors at time of recurrence are allowed to participate. There is no AI washout period required.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Adequate hepatic function within 14 days prior to registration for protocol therapy defined as meeting all of the following criteria:
  • aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases and
  • alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases and
  • total serum bilirubin ≤ 1.5 × ULN
  • Adequate renal function within 14 days prior to registration for protocol therapy defined by either of the following criteria:
  • serum creatinine ≤ 1.5 × ULN
  • OR if serum creatinine > 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 40 mL/min
  • Adequate hematologic function within 14 days prior to registration for protocol therapy defined as meeting all of the following criteria:
  • hemoglobin ≥ 9 g/dL
  • and absolute neutrophil count (ANC) ≥ 1.5 × 109/L
  • and platelet count ≥ 100 × 109/L
  • Provided written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information, approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC). NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required within 72 hours of study registration from women of childbearing potential. If the urine test cannot be confirmed as negative, a serum pregnancy test will be required.
  • Women of childbearing potential (WOCP) must be willing to use two effective methods of birth control such as use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence for the course of the study until 120 days after the last dose of study drug. The use of hormonal contraceptives is discouraged. NOTE: Women are considered to be of childbearing potential unless they are postmenopausal for at least 12 consecutive months or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • Male subjects capable of fathering a child must agree to use adequate contraception or total abstinence for the course of the study until 120 days after the last dose of the study drug.
  • NOTE: Male subjects will be considered as capable of fathering a child unless they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition).
  • Co-enrollment in an imaging biomarker study or other non-therapeutic study is allowed.

Who cannot join

  • Subjects meeting any of the criteria below may not participate in the study:
  • Prior treatment with any CDK 4/6 inhibitor.
  • Confirmed diagnosis of HER2 positive disease.
  • Known uncontrolled or symptomatic CNS metastases. Subjects with known brain metastasis will only be eligible after their tumors have been treated with definitive resection and /or radiotherapy and they are neurologically stable for at least 1 month off steroids.
  • Advanced, symptomatic, visceral spread with a life expectancy less than 4 months.
  • Prior (neo)adjuvant treatment with tamoxifen within the 12 months before study entry.
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  • Prior history of blood clots, pulmonary embolism or deep vein thrombosis.
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
  • Any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate subject participation in the clinical study.
  • Currently receiving any of the following substances and cannot be discontinued 7 days prior to study registration:
  • Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pomelos, star-fruit, and Seville oranges.
  • Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
  • Known strong inducers or inhibitors of CYP2D6.
  • Major surgery within 14 days prior to study registration or has not recovered from major side effects of surgery.
  • Known history of human immunodeficiency virus [(HIV) HIV 1/2 antibodies].
  • Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) (testing not mandatory)
  • Any clinically significant infection defined as any acute viral, bacterial, or fungal infection that requires specific treatment. NOTE: Anti-infective treatment must be completed ≥ 7 days prior to study registration.
  • Known allergy to palbociclib or any of its excipients
  • Presence of any non-healing wound, fracture, or ulcer within 28 days prior to study registration. NOTE: if fracture is at a metastatic site, is chronic, and no surgical treatment is planned, the subject can be enrolled.
  • Any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.
  • Any mental or medical condition that prevents the subject from giving informed consent or participating in the trial.
  • Treatment with any therapeutic investigational agent within 28 days prior to registration for protocol therapy. The subject must have recovered from the acute toxic effects of the regimen.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

  • Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

  • Michigan State University

    Lansing, Michigan, 48910

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • ProHealth Care

    Waukesha, Wisconsin, 53188

Other trials in United States

About this study

Official title: A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium BTCRC-BRE15-016

This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anticancer therapies for their advanced/metastatic disease.

Read the detailed description

OUTLINE: This is a multi-center trial.

INVESTIGATIONAL TREATMENT:

  • Palbociclib 125 mg will be administered orally once daily on days 1-21 (D1-D21) of each 28-day cycle. Subjects will not take palbociclib on D22-D28.
  • Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).

Palbociclib should be taken with food in combination with tamoxifen. Subjects should take their dose at approximately the same time each day.

It is encouraged, but not mandatory, that premenopausal subjects will also receive treatment with goserelin or equivalent (e.g., Lupron) given as an injectable subcutaneous implant on D1 of every 28 days cycle or every 3 months.

Disease assessments will be performed at the completion of every 2 cycles.

Treatment will continue until disease progression, unacceptable toxicity, subject refusal, or subject death either from progression of disease, the therapy itself, or from other causes. Subjects who voluntarily stop the study, have progressive disease, or unacceptable toxicities will be followed for a total of 24 months after discontinuation of study drug.

To demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration for protocol therapy:

Hematological (must meet ALL of the following criteria):

  • Absolute neutrophil count (ANC) ≥ 1.5 × 10 9/L
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100 × 10 9/L

Renal (must meet ONE of the following criteria):

  • Serum creatinine ≤ 1.5 × ULN
  • Serum creatinine > 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 40 mL/min

Hepatic (must meet ALL of the following criteria):

  • Aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
  • Total serum bilirubin ≤ 1.5 × ULN
Being tested
Palbociclib, Tamoxifen
Keywords
Palbociclib, Tamoxifen, CDK4/6 Inhibitor
Medical subject headings
Breast Neoplasms

What participants receive

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

  • PalbociclibDrug

    Also called Ibrance

    Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28.

  • TamoxifenDrug

    Also called Nolvadex

    Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).

Study groups in NCT02668666
Study groupRoleWhat they receive
Investigational TreatmentExperimentalSubjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Receives: Drug: Palbociclib; Drug: Tamoxifen

What is being measured

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

  1. Progression Free Survival (PFS) Per RECIST 1.1

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.

    Measured: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 61 months.

Secondary outcomes (4)

  1. Adverse Events

    Number of subjects experienced toxicity and tolerability of palbociclib and tamoxifen combination therapy, per Common Terminology Criteria for Adverse Events (CTCAE) v4.

    Measured: Adverse events (AEs) had been recorded from the time of consent until 30 days after discontinuation of study drug(s), up to a maximum of 56 months.

  2. Objective Response Rates (ORR)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    Per MD Anderson (MDA) criteria for bone only disease: CR, Complete sclerotic fill-in of lytic lesions on XR or CT and Normalization of signal intensity on MRI; PR, decrease of ≥ 50% in the sum of the perpendicular measurements of any lesion on XR, CT, or MRI.

    Overall Response (OR) = CR + PR.

    Measured: Up to a maximum of 61 months.

  3. Clinical Benefit Rate (CBR)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.

    Per MD Anderson (MDA) criteria for bone only disease: CR, Complete sclerotic fill-in of lytic lesions on XR or CT and Normalization of signal intensity on MRI; PR, decrease of ≥ 50% in the sum of the perpendicular measurements of any lesion on XR, CT, or MRI; PD > 25% increase in in the sum of measurable lesions or new bone metastases; SD, not meet criteria for CR/PR/PD.

    Clinical Benefit = CR +PR+SD lasting 24 weeks or longer.

    Measured: Up to a maximum of 61 months.

  4. Overall Survival (OS)

    To determine the percentage of overall survival at 2 years from the initiation of treatment. Overall survival is defined as the time from treatment start until death or date of last contact.

    Measured: 2 years

Timeline

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

  1. First posted29 Jan 2016 (estimated)
  2. Study start1 Feb 2017
  3. Primary completion3 Jul 2023
  4. Study completion24 Oct 2023

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02668666
Sponsor's protocol ID
BTCRC BRE15-016
Status last verified
Dec 2025
First submitted
27 Jan 2016
Last updated
20 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib and Tamoxifen in people with Hormone Receptor Positive Malignant Neoplasm of Breast and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Oana Danciu, MD at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Per RECIST 1.1 (time frame: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 61 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02668666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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