Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer
- Conditions
- Hormone Receptor-positive Breast Cancer
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria:<br><br> - Able to provide a written informed consent and any locally required authorization<br> prior to performing any protocol-related procedures,including screening evaluations.<br><br> - Female or male, age 18 years or older<br><br> - Eastern Cooperative Oncology Group (EGOG) performance status 0 through 2<br><br> - Pathologic confirmation of noninvasive breast cancer that is Hormone-receptor<br> positive (HR+) (ER [estrogen-receptor] and/or PR [progesterone-receptor] >/= 1%,<br> locally advanced, or metastatic disease.<br><br> - Invasive breast cancer is Human Epidermal Growth Factor Receptor 2 (HER2) negative<br> defined as 0 or 1+ by immunohistochemistry (IHC) or with an in situ hybridization<br> (ISH) ratio (HER2 gene copy/chromosome 17) < 2 or as defined by ASCO/CAP guidelines<br><br> - Measurable or non-measurable disease<br><br> - Any line of prior endocrine therapy in the unresectable and /or metastatic setting<br><br> - Adequate organ and marrow function as defined in protocol<br><br> - Participants must be willing and able to comply with the protocol for the duration<br> of the study. This compliance includes undergoing treatment, scheduled visits, and<br> examinations, including follow-up.<br><br> - If taking herbal or natural remedies that may have immune modulatory effects,<br> participants must be willing to discontinue them before first dose of cemiplimab<br><br> - Body weight greater than 30 kg<br><br>Exclusion Criteria:<br><br> - Participation in another clinical study with an investigational product during the<br> last 4 weeks<br><br> - Concurrent enrollment in another clinical study, unless it is an observational<br> (non-interventional) clinical study or during the follow-up period of an<br> interventional study.<br><br> - Received prior systemic cytotoxic chemotherapy for unresectable and/or metastatic<br> disease. Patients who received 1 cycle or fewer at least 3 months prior to<br> enrollment, which was discontinued for reasons other than disease progression, may<br> be enrolled at the discretion of the PI.<br><br> - Any previous treatment with a PD-1 or PD-L1 inhibitor, including cemiplimab.<br><br> - Nontreated brain metastasis. Treated brain metastasis is allowed if patients are<br> stable and off steroids for at least 2 months prior to enrollment.<br><br> - Leptomeningeal disease.<br><br> - History of another primary malignancy, except for malignancy treated with curative<br> intent; no known active disease for =2 years; adequately treated non-melanoma skin<br> cancer or lentigo maligna (without evidence of disease); or adequately treated<br> carcinoma in situ without evidence of disease (eg, cervical cancer in situ).<br><br> - Current or prior use of immunosuppressive medication within 14 days before the first<br> dose of cemiplimab, with the exceptions of intranasal, inhaled, topical steroids, or<br> local steroid injections (eg, intra-articular injection); systemic corticosteroids<br> at physiological doses, which are not to exceed 10 mg/day of prednisone or an<br> equivalent corticosteroid; or steroids as premedication for hypersensitivity<br> reactions (eg, CT scan premedication).<br><br> - Active or prior documented autoimmune or inflammatory disorders (including<br> inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with<br> the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis<br> syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease,<br> rheumatoid arthritis, hypophysitis, uveitis, pneumonitis etc]). The following are<br> exceptions to this criterion: (a) Patients with vitiligo or alopecia. (b) Patients<br> with hypothyroidism (eg, following Hashimoto syndrome) who are stable on hormone<br> replacement. (c) Any chronic skin condition that does not require systemic therapy.<br> (d) Patients without active disease in the last 5 years may be included but only<br> after consultation with the study physician. (e) Patients with celiac disease<br> controlled by diet alone.<br><br> - Prior treatment with other immune-modulating agents that was (a) within fewer than 4<br> weeks (28 days) prior to the first dose of cemiplimab or (b) associated with<br> immune-mediated AEs that were = grade 1 within 90 days prior to the first dose of<br> cemiplimab or (c) associated with toxicity that resulted in discontinuation of the<br> immune-modulating agent<br><br> - Prior treatment with idelalisib. The decision to treat with cemiplimab tumor types<br> for which cemiplimab and/or other anti-PD-1/ PD-L1 agents have demonstrated<br> efficacy, such as advanced CSCC, merits an individualized risk:benefit assessment by<br> the treating physician in discussion with the patient, in the event that a patient<br> had prior exposure to idelalisib.<br><br> - History of primary immunodeficiency.<br><br> - History of allogeneic organ transplant.<br><br> - Known allergy or history of hypersensitivity to cemiplimab or any excipient.<br><br> - Uncontrolled intercurrent illness including, but not limited to, ongoing or active<br> infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable<br> angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis,<br> active bleeding diatheses, or psychiatric illness/social situations that would limit<br> compliance with study requirements or compromise the ability of the subject to give<br> written informed consent.<br><br> - Known active infection, including tuberculosis (clinical evaluation that includes<br> clinical history, physical examination and radiographic findings, and TB testing in<br> line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg)<br> result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).<br> Patients with a past or resolved HBV infection (defined as the presence of hepatitis<br> B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for<br> the hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is<br> negative for HCV RNA. Note: This is applied only to patients with a known infection.<br> Screening tests for TB, hepatitis B and C, or HIV are not required.<br><br> - Receipt of live attenuated vaccination within 30 days prior to receiving cemiplimab.<br> Note: Patients, if enrolled, should not receive a live vaccine while receiving<br> cemiplimab and up to 30 days after the last dose of cemiplimab.<br><br> - Any condition that, in the opinion of the investigator, would interfere with the<br> evaluation of the study treatment or interpretation of patient safety or study<br> results.<br><br> - Patients with uncontrolled seizures.<br><br> - Major surgical procedure (as defined by the investigator) within 28 days prior to<br> the first dose of investigational product.<br><br> - Patient is currently pregnant or breast feeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recommended Phase 2 Dose (RP2D)
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR);Clinical Benefit Rate (CBR);Progression Free Survival (PFS)