What drugs or interventions are being studied?

pembrolizumab, chemotherapy, immunotherapy, radiation, cyclophosphamide, doxorubicin

Home › Trials › NCT03979508

Using abemaciclib to treat chemotherapy-resistant triple negative breast cancer

Window Trial of Abemaciclib for Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer (a BEAUTY Study*)

Phase 2 Interventional Mayo Clinic · NCT03979508

This study is testing if the drug abemaciclib can help people with chemotherapy-resistant triple negative breast cancer by looking at how it affects their immune response and the tumor itself.

Quick facts

Phase	Phase 2
Study type	Interventional
Enrollment	200 (estimated)
Ages	18 Years and up
Sex	Female
Sponsor	Mayo Clinic Academic / other
Drugs / interventions	pembrolizumab, chemotherapy, immunotherapy, radiation, cyclophosphamide, doxorubicin
Locations	3 sites (Scottsdale, Arizona and 2 other locations)
Trial ID	NCT03979508 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effectiveness of abemaciclib in patients with surgically resectable, chemotherapy-resistant triple negative breast cancer (TNBC). The study is divided into two cohorts: one receiving neoadjuvant chemotherapy without pembrolizumab and the other with pembrolizumab. The primary objective is to assess the impact of abemaciclib on the CD8/FOXP3 ratio, which is a marker of immune response in the tumor microenvironment. Secondary objectives include evaluating the drug's toxicity and its effects on various tumor characteristics and immune markers.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with histologically confirmed triple negative invasive breast cancer that is resectable and has not responded to prior chemotherapy.

Not a fit: Patients with non-triple negative breast cancer or those who have not undergone neoadjuvant chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with chemotherapy-resistant triple negative breast cancer.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific application of abemaciclib in chemotherapy-resistant TNBC is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria

Inclusion Criteria:

* Women of age \>=18 years
* PRE-REGISTRATION: Clinical T1-4, N0-3, M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging version 8.

  * Note: Benign breast disease, lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) in the ipsilateral or contralateral breast is allowed.
  * Note: Additional ipsilateral or contralateral invasive breast cancer is allowed. The index lesion is the largest triple-negative, chemotherapy-resistant lesion.
* PRE-REGISTRATION: Histological confirmation of triple negative invasive breast cancer (defined as estrogen receptor \[ER\] =\< 10%, progesterone receptor \[PR\] =\< 10% and HER2 not amplified by in situ hybridization \[ISH\] or immunohistochemistry \[IHC\] 0/1) at diagnosis.
* PRE-REGISTRATION: Cohort A: CLOSED TO PRE-REGISTRATION and REGISTRATION as of protocol amendment 6 (04/14/2023) Neoadjuvant chemotherapy (NAC) with one of the following regimens that was not discontinued early due to intolerability with less than 50% of planned treatment given due to disease progression or patient request:

  * Paclitaxel or docetaxel followed by one of the following: the combination of doxorubicin and cyclophosphamide (AC); the combination of epirubicin and cyclophosphamide (EC) or the combination of 5-fluorouracil, epirubicin and cyclophosphamide (FEC)

    * Note: Carboplatin may be added to these regimens
  * AC or EC or FEC followed by docetaxel or paclitaxel

    * Note: Carboplatin may be added to these regimens
  * Docetaxel in combination with doxorubicin and cyclophosphamide (TAC)
  * Docetaxel in combination with cyclophosphamide (TC) (for patients who are not candidates for anthracyclines)
  * Carboplatin or cisplatin in combination with a taxane (paclitaxel, docetaxel, or nab-paclitaxel) (for patients who are not candidates for anthracyclines)
* PRE-REGISTRATION: Cohort B: Neoadjuvant chemotherapy (NAC) with one of the following regimens in combination with pembrolizumab that was not discontinued early due to intolerability with less than 50% of planned treatment given due to disease progression or patient request:

  * Paclitaxel or docetaxel followed by one of the following: the combination of doxorubicin and cyclophosphamide (AC); the combination of epirubicin and cyclophosphamide (EC) or the combination of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) Note: Carboplatin may be added to these regimens
  * AC or EC or FEC followed by docetaxel or paclitaxel \[Note: Carboplatin may be added to these regimens\]
  * Docetaxel in combination with doxorubicin and cyclophosphamide (TAC)
  * Docetaxel in combination with cyclophosphamide (TC)
  * Carboplatin or cisplatin in combination with a taxane (paclitaxel, docetaxel, or nab-paclitaxel)
* PRE-REGISTRATION: Residual lesion/enhancement seen in the breast on breast imaging performed after completion of NAC.
* PRE-REGISTRATION: Able to swallow oral medication.
* PRE-REGISTRATION: Willing to undergo biopsy for research.
* PRE-REGISTRATION: Willing to provide tissue and blood samples for correlative research purposes.
* PRE-REGISTRATION: Willing to stop use of strong and moderate inducers and/or strong inhibitors of cytochrome P450 3A =\< 7 days prior to registration.
* PRE-REGISTRATION: Provide written informed consent.
* REGISTRATION: Registration must occur =\< 56 days after last dose of NAC.
* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2.
* REGISTRATION: COHORT B GROUP 4 ONLY: The following laboratory values obtained after completion of NAC but =\< 14 days prior to registration:
* REGISTRATION: COHORT B GROUP 4 ONLY: Absolute neutrophil count (ANC) \>= 1500/mm\^3.
* REGISTRATION: COHORT B GROUP 4 ONLY: Platelets (PLT) \>= 100,000/mm\^3.
* REGISTRATION: COHORT B GROUP 4 ONLY: Hemoglobin (HgB) \>= 8.0 g/dL.
* REGISTRATION: COHORT B GROUP 4 ONLY: Total bilirubin =\< 1.5 x upper limit of normal (ULN).
* REGISTRATION: COHORT B GROUP 4 ONLY: Aspartate transaminase (AST) serum glutamic oxaloacetic transaminase (SGOT) =\< 3 x ULN.
* REGISTRATION: COHORT B GROUP 4 ONLY: Alanine transaminase (ALT) serum glutamate pyruvate transaminase (SGPT) =\< 3 x ULN.
* REGISTRATION: COHORT B GROUP 4 ONLY: Serum creatinine =\< 1.5 x ULN.
* REGISTRATION: GROUP 2 ONLY: Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only.

Exclusion Criteria:

* PRE-REGISTRATION: History of deep venous thrombosis (DVT) or pulmonary embolisms (PE) =\< 12 months prior to preregistration; OR Active DVT and/or PE requiring anti-coagulant therapy.

  * NOTE: Patients who are on anti-coagulant therapy for maintenance are eligible as long as the DVT and/or PE was \> 12 months prior to enrollment and there is no evidence for active thrombosis (either DVT or PE).
  * NOTE: Patients on anticoagulation are eligible; however peri-biopsy and peri-surgical management of anticoagulation is per the institutional standard of care.
* PRE-REGISTRATION: Prior treatment with CDK 4/6 inhibitors (e.g. palbociclib, ribociclib, abemaciclib, etc.)
* PRE-REGISTRATION: Prior treatment with radiation for this breast cancer.
* PRE-REGISTRATION: Prior incisional or excisional breast biopsy for this cancer.
* PRE-REGISTRATION: Any contraindications to pre-registration biopsy (such as bleeding diatheses, etc.).
* PRE-REGISTRATION: Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.
* PRE-REGISTRATION: Other active malignancy =\< 3 years prior to registration.

  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
  * NOTE: If there is a history of prior malignancy, they must not be receiving another specific treatment for prior malignancy.
* PRE-REGISTRATION: Biopsy proven Stage IV breast cancer.
* PRE-REGISTRATION: Serious pre-existing medical conditions that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g., estimated creatinine clearance \< 30 ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea).
* PRE-REGISTRATION: History of any of the following conditions:

  * Syncope of cardiovascular etiology.
  * Ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation).
  * Sudden cardiac arrest.
  * NOTE: Patients on anticoagulation are eligible; however peri-biopsy and peri-surgical management of anticoagulation is per the institutional standard of care.
* REGISTRATION: COHORT B GROUP 4: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

  * Pregnant persons.
  * Nursing persons.
  * Persons of childbearing potential who are unwilling to employ adequate contraception.
* REGISTRATION: COHORT B GROUP 4: Failure to recover to grade 1 or lower from effects of neoadjuvant chemotherapy.

  * Exceptions: Residual alopecia and grade 2 peripheral neuropathy are allowed.
* REGISTRATION: COHORT B GROUP 4: Concurrent use of strong and moderate inducers and/or strong inhibitors of cytochrome P450 3A =\< 7 days prior to registration.
* REGISTRATION: COHORT B GROUP 4: Known infections as follows (NOTE: Screening is not required for enrollment):

  * Active systemic bacterial infection requiring intravenous antibiotics.
  * Active fungal infection (requiring intravenous or oral antifungal treatment).
  * Detectable viral infections (e.g. known human immunodeficiency virus \[HIV\], known active hepatitis B or C).
* REGISTRATION: COHORT B GROUP 4: Concurrent use of chemotherapy, radiotherapy, immunotherapy, or other components of neoadjuvant treatment.

  * NOTE: Patients must complete all elements of NAC ≥21 days prior to starting abemaciclib.

Where this trial is running

Scottsdale, Arizona and 2 other locations

Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)

Study contacts

Principal investigator: Matthew P. Goetz, M.D. — Mayo Clinic in Rochester

How to participate

Review the eligibility criteria above with your treating physician.
Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov → Find more trials like this →

Conditions Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Breast Ductal Carcinoma In Situ Breast Fibrocystic Change Breast Lobular Carcinoma In Situ Invasive Breast Carcinoma Prognostic Stage I Breast Cancer AJCC v8

Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.