Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane. The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). 152 patients were enrolled.

Key facts

Study ID

NCT03858972

Run by

Odonate Therapeutics, Inc.

People needed

152

Starts

2019-02-05

Expected to finish

2021-06-11

Last updated by the study team

2021-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male patients at least 18 years of age
• Histologically or cytologically confirmed breast cancer
• HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status
• HR (ER and/or PgR) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status
• Measurable disease per RECIST 1.1, including bone-only disease with measurable lytic component.
• Patients with bone-only metastatic cancer must have a measurable lytic or mixed lytic-blastic lesion that can be accurately assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a measurable lytic component (ie, blastic-only metastasis) are not eligible.
• Known metastases to the CNS are permitted but not required. The following criteria apply:
• Patients must be neurologically stable and either off corticosteroids or currently treated with a maximum daily dose of 4 mg of dexamethasone (or equivalent), with no increase in corticosteroid dose within 7 days prior to Enrollment (defined as the time of Sponsor approval of treatment dose)
• Patients with a history of CNS metastases but with no current evidence of CNS lesions following local therapy are eligible
• Patients may have CNS metastases that are stable or progressing radiologically
• Patients with current evidence of leptomeningeal disease are not eligible
• Patients may have untreated brain metastases or previously treated brain metastases, as long as no immediate local CNS-directed therapy is indicated
• Any prior whole brain radiation therapy must have been completed > 14 days prior to the date of Enrollment
• Prior stereotactic brain radiosurgery is permitted
• CNS surgical resection must have been completed > 28 days prior to the date of Enrollment; patient must have complete recovery from surgery
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
• Documented (including de novo): (a) locally advanced breast cancer that is not considered curable by surgery and/or radiation; or (b) metastatic breast cancer
• Adequate hematologic, hepatic and renal function, as evidenced by:
• Absolute neutrophil count (ANC) ≥ 1,500/μL without colony-stimulating factor support
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 10 g/dL without need for hematopoietic growth factor or transfusion support
• Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome
• Alanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present then < 5 × ULN
• Aspartate aminotransferase (AST) < 3 × ULN unless hepatic metastases are present then < 5 × ULN

You may not qualify if…

• Two or more prior chemotherapy regimens for advanced disease
• Prior treatment with a taxane at any dose
• Prior treatment with capecitabine at any dose
• Current evidence of leptomeningeal disease
• Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the Study
• Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
• Active hepatitis B or active hepatitis C infection
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this Study.
• Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
• Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain radiosurgery), chemotherapy, biologic therapy, or therapy in an investigational clinical study, ≤ 14 days prior to the date of Enrollment
• Major surgery ≤ 28 days prior to the date of Enrollment; patient must have complete recovery from surgery
• Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage, or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP)3A pathway (patients should discontinue taking any regularly-taken medication that is a strong inhibitor or inducer of the CYP3A pathway)
• History of hypersensitivity or unexpected reactions to capecitabine, fluoropyrimidine agents or any of their ingredients
• Known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.
• Pregnant or breastfeeding
• If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the Study
• Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of Enrollment

Where it is running

• Innovative Clinical Research Institute — Whittier, California, United States
• Rocky Mountain Cancer Center — Lakewood, Colorado, United States
• Sarah Cannon Research Institute - Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists and Research Institute — St. Petersburg, Florida, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• New York Cancer and Blood Specialists — East Setauket, New York, United States
• West Cancer Center — Germantown, Tennessee, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Border Medical Oncology — Albury, New South Wales, Australia
• Hopital Maisonneuve-Rosemont — Montreal, Canada
• Center Hospitalier de Montreal CHUM McPeak Sirois — Montreal, Canada
• CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital — Montreal, Canada
• McGill University Health Center — Montreal, Canada
• CHU de Quebec-University Laval — Québec, Canada
• Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre — Sherbrooke, Canada
• Kyungpook National University Hospital — Daegu, South Korea
• National Cancer Center — Goyang, South Korea
• Gangnam Severance Hospital — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Ajou University Hospital — Suwon, South Korea
• Hospital Teresa Herrera Materno-Infantil (CHUAC) — A Coruña, Spain
• Fundacion Jimenez Diaz — Madrid, Spain
• Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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