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Breast CancerPhase 2CONTESSA 2NCT03858972

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

A Phase 2 study testing Tesetaxel and Capecitabine in people with Breast Cancer, run by Odonate Therapeutics, Inc. at 25 sites in 6 countries.

Terminated

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Tesetaxel and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
25 sitesin 6 countries
Study dates
5 Feb 2019to 11 Jun 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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.
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  • 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
  • Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present then < 5 × ULN
  • Calculated creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula or local standard)
  • Serum albumin ≥ 3.0 g/dL
  • Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 1.5 × ULN, unless the patient is on a therapeutic anticoagulant
  • Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy
  • Ability to swallow an oral solid-dosage form of medication
  • A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization)
  • Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 70 days after the last dose of Study treatment
  • Acceptable methods include: copper intrauterine device or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm
  • Male patients must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 130 days after the last dose of Study treatment
  • Acceptable methods include: male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success
  • Written informed consent and authorization to use and disclose health information
  • Ability to comprehend and comply with the requirements of the Study

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

25 sites in 6 countries.

25 sites in 6 countries

United States9 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • New York Cancer and Blood Specialists

    East Setauket, New York, 11733

  • Sarah Cannon Research Institute - Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Rocky Mountain Cancer Center

    Lakewood, Colorado, 80228

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Florida Cancer Specialists and Research Institute

    St. Petersburg, Florida, 33705

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Canada6 sites

  • Hopital Maisonneuve-Rosemont

    Montreal, H1T 4B3

  • Center Hospitalier de Montreal CHUM McPeak Sirois

    Montreal, H2X 3E4

  • CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital

    Montreal, H3T IE2

  • McGill University Health Center

    Montreal, H4J 3J1

  • CHU de Quebec-University Laval

    Québec, G1S 4L8

  • Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre

    Sherbrooke, J1H 5N4

Other trials in Canada

South Korea5 sites

  • Kyungpook National University Hospital

    Daegu

  • National Cancer Center

    Goyang

  • Gangnam Severance Hospital

    Seoul, 06273

  • Asan Medical Center

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Spain2 sites

  • Hospital Teresa Herrera Materno-Infantil (CHUAC)

    A Coruña, 15006

  • Fundacion Jimenez Diaz

    Madrid, 28040

Other trials in Spain

Taiwan2 sites

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

Australia1 site

  • Border Medical Oncology

    Albury, New South Wales, 2640

Other trials in Australia

About this study

Official title: Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

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.

Read the detailed description

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with HER2 negative, HR Positive, LA/MBC not previously treated with a taxane in the neoadjuvant, adjuvant or metastatic setting. This Study complements CONTESSA, a multinational, multicenter, randomized, Phase 3 study in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. 152 patients were enrolled, including 149 who received treatment. Patients are administered tesetaxel at 27 mg/m2 orally once every 21 days on the first day of each 21-day cycle plus capecitabine at 825 mg/m2 orally twice daily (for a total daily dose of 1,650 mg/m2) for 14 days of each 21-day cycle. Patients in the dense pharmacokinetics (PK) cohort receive a single dose of capecitabine monotherapy prior to starting the combination regimen. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. The primary efficacy endpoint is ORR as assessed by the IRC. The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS). CONTESSA 2 also investigates the PK of tesetaxel.

Conditions
Breast Cancer
Being tested
Tesetaxel, Capecitabine
Keywords
Tesetaxel, Capecitabine, HER2 negative, Combination of tesetaxel and capecitabine, Taxane-naive, Locally advanced or metastatic breast cancer, Hormone receptor positive, Metastatic breast cancer (MBC), Breast cancer, Central nervous system (CNS) metastases, de novo metastatic breast cancer, Oral chemotherapy, Taxane
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • TesetaxelDrug

    Tesetaxel plus reduced dose of capecitabine

  • CapecitabineDrug

    Reduced dose of capecitabine

Study groups in NCT03858972
Study groupRoleWhat they receive
Tesetaxel (oral) and capecitabine (oral)ExperimentalCohort 1: Tesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle. Cohort 2: On Cycle 1, Day -1, either a single morning dose of capecitabine at 825 mg/m2 (Cohort 2A) or 1,250 mg/m2 (Cohort 2B). On Cycle 1, Day 1, a single dose of tesetaxel (27 mg/m2), followed 2 hours later by capecitabine (825 mg/m2), followed by an evening dose of capecitabine (825 mg/m2). Capecitabine (825 mg/m2) twice daily (total daily dose of 1,650 mg/m2) beginning with the morning dose on Day 2 through evening dose on Day 14 of Cycle 1. Starting with Cycle 2, tesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle.
Receives: Drug: Tesetaxel; Drug: Capecitabine

What is being measured

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

  1. ORR as assessed by the IRC

    Measured: Approximately 2.0-2.5 years

Secondary outcomes (8)

  1. DoR as assessed by the IRC

    Measured: Approximately 2.0-2.5 years

  2. PFS as assessed by the IRC

    Measured: Approximately 2.0-2.5 years

  3. DCR as assessed by the IRC

    Measured: Approximately 2.0-2.5 years

  4. OS

    Measured: Approximately 3.0-3.5 years

  5. Central nervous system (CNS) ORR as assessed by the CNS IRC in patients with CNS metastases at baseline

    Measured: Approximately 2.0-2.5 years

  6. CNS DoR as assessed by the CNS IRC in patients with CNS metastases at baseline

    Measured: Approximately 2.0-2.5 years

  7. CNS PFS as assessed by the CNS IRC in patients with CNS metastases at baseline or a history of CNS metastases and in the intent-to-treat (ITT) population

    Measured: Approximately 2.0-2.5 years

  8. CNS OS in patients with CNS metastases at baseline or a history of CNS metastases

    Measured: Approximately 3.0-3.5 years

Timeline

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

  1. First posted1 Mar 2019
  2. Study start5 Feb 2019
  3. Primary completion11 Jun 2021
  4. Study completion11 Jun 2021

Why it stopped: The Sponsor has discontinued the development of tesetaxel

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
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03858972
Sponsor's protocol ID
ODO-TE-B201
Acronym
CONTESSA 2
Status last verified
Jul 2021
First submitted
26 Feb 2019
Last updated
30 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tesetaxel and Capecitabine in people with Breast Cancer, run by Odonate Therapeutics, Inc. at 25 sites in 6 countries.

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 38 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 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada, South Korea, Spain, Taiwan and 1 more country. 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?

The study was stopped early (reason given: The Sponsor has discontinued the development of tesetaxel). Results are not available in the source record.

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?

ORR as assessed by the IRC (time frame: Approximately 2.0-2.5 years). 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 NCT03858972.

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 30 Jul 2021.

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