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Breast NeoplasmPhase 2NCT04305236

Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer

A Phase 2 study testing Abemaciclib and Fulvestrant in people with Breast Neoplasm and Hormone Receptor Positive Breast Carcinoma, run by University of California, Irvine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase 2 single-arm, open-label determining efficacy of Neo-adjuvant Abemaciclib and Fulvestrant in subjects with Hormone receptor positive patients with localized non-metastatic breast cancer who develop local recurrence while on adjuvant endocrine therapy with molecular evidence of endocrine resistance. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Abemaciclib and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
23 Jul 2020to 16 Feb 2022
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a diagnosis of HR+ breast cancer. To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines (Hammond et al. 2010):
  • 1. For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC) (Hammond et al. 2010).
  • Patients must have Loco regional breast cancer (Stage I, Stage II and stage III per AJCC 8th edition criteria for staging of breast cancer)
  • Patients must have localized recurrence while on adjuvant endocrine therapy
  • Patients must have any known molecular evidence of endocrine resistance by next generation sequencing
  • Age ≥ 18 years.
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  • ECOG performance status 0-1
  • Have post-menopausal status as defined by following:
  • Prior bilateral oophorectomy
  • Age ≥ 60 years
  • Age < 60 and amenorrheic (non-treatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or chemotherapy) for at least 12 months. Follicle-stimulating hormone (FSH) and estradiol must be in the postmenopausal range.
  • Have at least one measurable disease as defined per RECIST 1.1
  • Adequate organ and marrow function as defined below:
  • Hemoglobin* > 8 g/dL
  • Absolute neutrophil count ≥ 1,500/mcL
  • Total bilirubin ≤ 1.5 X institutional ULN, Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted
  • AST (SGOT)/ALT (SPGT) ≤ 2.5 X institutional ULN
  • Creatinine ≤ 1.5 X institutional ULN
  • *Patients may receive transfusion of packed red blood cells (PRBC) to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after the PRBC transfusion.
  • Able to swallow oral medications
  • Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and screening for the study.
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy).
  • Any known markers of response or resistance to CDK 4/6 inhibitors to be present in the biopsy specimen
  • If patients have been treated with prior Neo-Adjuvant chemotherapy at the time of primary diagnosis and not at the time of recurrence, they will be included in the study.
  • Must be able to sign a written informed consent, are reliable, willing to be available for the duration of the study and are willing to follow study procedures

Who cannot join

  • Stage IV metastatic breast cancer
  • 1. This study will utilize the American Joint Committee on Cancer (AJCC) staging system, eight edition that provides a strategy for grouping patients with respect to prognosis. The AJCC has designated staging by TNM classification. The researchers will also review tumor size, lymph node status, and estrogen-receptor and progesterone-receptor levels in the tumor tissue.
  • Patients with HER2 positive and triple negative breast cancer
  • 1. To fulfill the requirement of HER2- and Triple negative disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 or should not express ER or PR receptors by either IHC or in-situ hybridization (ISH) as defined in the relevant ASCO/CAP guidelines (Wolff et al. 2013).
  • Inflammatory breast cancer
  • Newly diagnosed endocrine naïve patients
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  • No molecular evidence of endocrine resistance
  • Prior treatment with any CDK 4/6 inhibitor and/or Fulvestrant
  • Pre-menopausal women
  • Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study. If a patient is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the principal investigator is required to establish eligibility
  • Have had major surgery within 14 days prior to enrollment to allow for post-operative healing of the surgical wound
  • Have initiated bisphosphonates or approved RANK ligand therapy for breast cancer with osseous metastasis, if patients are received Zolendronic acid or Denosumab in the adjuvant manner then such patients will be allowed participate
  • Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel or preexisting Crohn's disease or ulcerative colitis , interstitial lung disease, severe dyspnea at rest, any pre-existing chronic condition resulting in baseline grade 2 or higher diarrhea)
  • Have a personal history of any of the following conditions: syncope or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest
  • Have a history of any other cancer (except for non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of three years or have received an autologous or allogeneic stem-cell transplant
  • Have an active bacterial or fungal infection or a detectable viral infection (for example HIV or viral hepatitis). Screening is not required for enrollment
  • Recent therapy with a biologic agent or a monoclonal therapy is excluded. Wash out of at least three half-lives of monoclonal antibody would be required to be enrolled.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868

Other trials in United States

About this study

Official title: A Phase II Open Label Trial of Neo-Adjuvant Abemaciclib With Fulvestrant in Patients Who Develop Localized Recurrence While on Adjuvant Endocrine Therapy With Molecular Evidence of Endocrine Resistance

This is a phase 2 single-arm, open-label determining efficacy of Neo-adjuvant Abemaciclib and Fulvestrant in subjects with Hormone receptor positive patients with localized non-metastatic breast cancer who develop local recurrence while on adjuvant endocrine therapy with molecular evidence of endocrine resistance.

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 NCT04305236
Study groupRoleWhat they receive
Abemaciclib and FulvestrantExperimentalAbemaciclib will be administered orally at the dose of 150 mg twice daily. Fulvestrant will be administered intramuscularly at an initial loading dose of 500mg on days 1 and 15 of the first cycle and then 500 mg intramuscularly every first day of each subsequent cycle. One cycle is 28 days.
Receives: Drug: Abemaciclib; Drug: Fulvestrant

What is being measured

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

  1. Percentage of Participants With a Pathological Complete Response

    This is defined as the percentage of subjects who achieve a pathological complete response (pCR). A pCR is defined by no evidence of tumor cells in the final surgical specimen.

    Measured: From start of study treatment to surgery, on average we expect 6 months.

Secondary outcomes (6)

  1. Overall Response Rate

    To assess the overall response rate to the combination of Abemaciclib and Fulvestrant. Overall response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR

    Measured: From start of study treatment to surgery, on average we expect 6 months.

  2. Percentage of Participants Who Undergo Breast Conserving Surgery

    This is defined as the percentage of subjects who undergo breast conserving surgery after receiving Abemaciclib and Fulvestrant

    Measured: From start of study treatment to surgery, on average we expect 6 months.

  3. Recurrence Disease Free Survival

    Recurrence disease free survival will be defined as the time from surgery until patient develops recurrence.

    Measured: Up to 5 years

  4. Percentage of Grade 3-5 Adverse Events

    To evaluate the safety and tolerability of administering Abemaciclib and Fulvestrant. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

    Measured: From start of study treatment to surgery, on average we expect 6 months.

  5. Percentage Change in Ki 67

    Percentage change in the Ki 67 will be evaluated from baseline to the treated specimen after breast surgery

    Measured: From start of study treatment to surgery, on average we expect 6 months.

  6. Preoperative Endocrine Prognostic Index Score

    The preoperative endocrine prognostic index (PEPI) Score is a score that is used in clinical trials to assess response to Neo-Adjuvant endocrine therapy. The PEPI score takes into account the tumor and nodal stage, level of ER expression and Ki 67 following neoadjuvant endocrine therapy.

    Measured: From start of study treatment to surgery, on average we expect 6 months.

Timeline

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

  1. First posted12 Mar 2020
  2. Study start23 Jul 2020
  3. Primary completion16 Feb 2022
  4. Study completion16 Feb 2022

Why it stopped: Halted due to study funding

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04305236
Sponsor's protocol ID
UCI 18-79 [HS# 2020-5660]
Other IDs
2020-5660
Status last verified
May 2023
First submitted
9 Mar 2020
Last updated
6 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib and Fulvestrant in people with Breast Neoplasm and Hormone Receptor Positive Breast Carcinoma, run by University of California, Irvine at 1 site 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 25 inclusion and 17 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: stopped early, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 Mar 2023). 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?

Percentage of Participants With a Pathological Complete Response (time frame: From start of study treatment to surgery, on average we expect 6 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 NCT04305236.

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 6 Jun 2023.

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