Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2019 |
Start Date: | December 21, 2017 |
End Date: | March 2023 |
Contact: | Jennifer Baca |
Email: | jbaca@odonate.com |
Phone: | 910-769-1557 |
A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients
with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or
adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel
plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on
progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee
(IRC). Approximately 600 patients will be enrolled.
with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or
adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel
plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on
progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee
(IRC). Approximately 600 patients will be enrolled.
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel plus a
reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with
HER2 negative, HR positive locally advanced or metastatic breast cancer (LA/MBC) previously
treated with a taxane in the neoadjuvant or adjuvant setting. Approximately 600 patients will
be enrolled.
Patients randomly assigned to Arm A (tesetaxel plus a reduced dose of capecitabine) will be
administered:
- Tesetaxel (27 mg/m2) orally once every 21 days on Day 1 of each 21-day cycle; and
- Capecitabine (825 mg/m2) orally twice daily (in the morning and evening after a meal,
for a 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.
Patients randomly assigned to Arm B (approved dose of capecitabine alone) will be
administered:
- Capecitabine (1,250 mg/m2) orally twice daily (in the morning and evening after a meal,
for a total daily dose of 2,500 mg/m2), beginning with the evening dose on Day 1 through
the morning dose on Day 15 of each 21-day cycle
Dose modifications for tesetaxel and/or capecitabine are described in the study protocol.
Patients will be treated until documentation of progressive disease (PD), evidence of
unacceptable toxicity, or other decision to discontinue treatment. Capecitabine is an oral
chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. The primary
endpoint is PFS as assessed by an IRC. The secondary efficacy endpoints are overall survival
(OS), objective response rate (ORR) as assessed by an IRC, and disease control rate (DCR) as
assessed by an IRC.
reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with
HER2 negative, HR positive locally advanced or metastatic breast cancer (LA/MBC) previously
treated with a taxane in the neoadjuvant or adjuvant setting. Approximately 600 patients will
be enrolled.
Patients randomly assigned to Arm A (tesetaxel plus a reduced dose of capecitabine) will be
administered:
- Tesetaxel (27 mg/m2) orally once every 21 days on Day 1 of each 21-day cycle; and
- Capecitabine (825 mg/m2) orally twice daily (in the morning and evening after a meal,
for a 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.
Patients randomly assigned to Arm B (approved dose of capecitabine alone) will be
administered:
- Capecitabine (1,250 mg/m2) orally twice daily (in the morning and evening after a meal,
for a total daily dose of 2,500 mg/m2), beginning with the evening dose on Day 1 through
the morning dose on Day 15 of each 21-day cycle
Dose modifications for tesetaxel and/or capecitabine are described in the study protocol.
Patients will be treated until documentation of progressive disease (PD), evidence of
unacceptable toxicity, or other decision to discontinue treatment. Capecitabine is an oral
chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. The primary
endpoint is PFS as assessed by an IRC. The secondary efficacy endpoints are overall survival
(OS), objective response rate (ORR) as assessed by an IRC, and disease control rate (DCR) as
assessed by an IRC.
Inclusion Criteria:
1. Female or male patients at least 18 years of age
2. Histologically or cytologically confirmed breast cancer
3. 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
4. HR (estrogen receptor [ER] and/or progesterone receptor [PgR]) positive disease based
on local testing: ASCO/CAP guidelines should be utilized for assessing HR status
5. Measurable disease per RECIST 1.1 or bone-only disease with lytic component
- Patients with bone-only metastatic cancer must have a lytic or mixed
lytic-blastic lesion that can be accurately assessed by computerized tomography
(CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without
a 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
randomization
- 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 randomization
- Prior stereotactic brain radiosurgery is permitted
- CNS surgical resection must have been completed > 28 days prior to the date
of randomization; patient must have complete recovery from surgery
6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
7. Prior therapy (at least one completed dose) with a taxane-containing regimen in the
neoadjuvant or adjuvant setting
8. Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant,
or metastatic setting, where indicated by local regulation or Investigator judgment.
9. 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.
10. Documented disease recurrence or disease progression of: (a) locally advanced disease
that is not considered curable by surgery and/or radiation; or (b) metastatic disease.
11. 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
12. Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) 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
13. Ability to swallow an oral solid-dosage form of medication
14. 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)
15. 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 devices or double barrier methods,
including male/female condoms with spermicide and use of contraceptive sponge,
cervical cap, or diaphragm
16. Male patients must use an effective, non-hormonal form of contraception from screening
throughout the treatment phase and until 130 days after last dose of study treatment
• Acceptable methods include male/female condoms with spermicide, or vasectomy with
medical confirmation of surgical success
17. Written informed consent and authorization to use and disclose health information
18. Ability to comprehend and comply with the requirements of the study
Exclusion Criteria:
1. Two or more prior chemotherapy regimens for advanced disease
2. Prior treatment with a taxane in the metastatic setting
3. Prior treatment with capecitabine at any dose
4. Current evidence of leptomeningeal disease
5. 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 sponsor medical team, other cancer that has a very low risk of interfering with
the safety or efficacy endpoints of the study
6. 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.
7. Active hepatitis B or active hepatitis C infection
8. 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
9. Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
10. History of hypersensitivity to taxanes; hypersensitivity to the solvent does not
preclude patient participation in this study
11. Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic
brain surgery), chemotherapy, biologic therapy, or therapy in an investigational
clinical study, ≤ 14 days prior to the date of randomization
12. Major surgery ≤ 28 days prior to the date of randomization; patient must have complete
recovery from surgery
13. 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)
14. History of hypersensitivity or unexpected reactions to capecitabine, other
fluoropyrimidine agents, or any of their ingredients
15. 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.
16. Pregnant or breastfeeding
17. If, in the opinion of the Investigator, the patient is deemed unwilling or unable to
comply with the requirements of the study
18. Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days
prior to the date of randomization
We found this trial at
91
sites
16918 Dove Canyon Road
San Marcos, California 92069
San Marcos, California 92069
Principal Investigator: Michael Kosmo, MD
Phone: 760-452-3909
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24 Sturtevant St
Orlando, Florida 32806
Orlando, Florida 32806
Principal Investigator: Regan Rostofer, MD
Phone: 321-841-4348
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Albany, New York 12206
Principal Investigator: Karen Tedesco, MD
Phone: 518-489-2607
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801 University Boulevard Southeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
Principal Investigator: Ursa Brown-Glaberman, MD
Phone: 505-925-0391
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Allentown, Pennsylvania 18105
Principal Investigator: Nicolas Lamparella, MD
Phone: 610-402-1642
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Anaheim, California 92801
Principal Investigator: Veena Charu, MD
Phone: 714-999-1465
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Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos, MD
Phone: 706-353-2990
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6501 Truxtun Avenue
Bakersfield, California 93309
Bakersfield, California 93309
Principal Investigator: Shawn Shambaugh, MD
Phone: 661-862-7178
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Principal Investigator: Katherine Tkaczuk, MD
Phone: 410-328-8611
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Baltimore, Maryland 21204
Principal Investigator: Madhu Chaudhry, MD
Phone: 443-849-8089
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Bedford, Texas 76022
Principal Investigator: Thomas Anderson, MD
Phone: 817-359-9000
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Bellevue, Washington 98004
Principal Investigator: Stephen Lemon, MD
Phone: 425-635-6081
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Biddeford, Maine 04005
Principal Investigator: Peter Rubin, MD
Phone: 207-396-8228
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Billings, Montana 59102
Principal Investigator: Patrick Cobb, MD
Phone: 406-238-6684
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Sara Tolaney, MD
Phone: 617-632-3478
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brick, New Jersey 08724
Principal Investigator: Apruv Agrawal, MD
Phone: 609-489-3257
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Chandler, Arizona 85224
Principal Investigator: Sujith Kalmadi, MD
Phone: 480-398-7671
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Chapel Hill, North Carolina 27599
Principal Investigator: Trevor Jolly, MD
Phone: 984-974-8564
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8700 Jones Mill Road
Chevy Chase, Maryland 20815
Chevy Chase, Maryland 20815
Principal Investigator: Frederick Smith, MD
Phone: 301-690-0710
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5758 South Maryland Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
Principal Investigator: Rita Nanda, MD
Phone: 773-834-9774
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Columbus, Ohio 43212
Principal Investigator: Nicole Williams, MD
Phone: 614-685-0380
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Dallas, Texas 75201
Principal Investigator: Jay Courtright, MD
Phone: 972-566-4291
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Dallas, Texas 75231
Principal Investigator: Kristi McIntyre, MD
Phone: 214-265-2080
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Dallas, Texas 75246
Principal Investigator: Joyce O'Shaughnessy, MD
Phone: 214-370-1000
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24 Hospital Avenue
Danbury, Connecticut 06810
Danbury, Connecticut 06810
Principal Investigator: Wenli Gao, MD
Phone: 203-739-7997
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2799 W Grand Blvd
Detroit, Michigan 48202
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Haythem Ali, MD
Phone: 313-916-2438
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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East Brunswick, New Jersey 70072
Principal Investigator: Edward Licitra, MD
Phone: 732-390-7750
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235 North Belle Mead Avenue
East Setauket, New York 11733
East Setauket, New York 11733
Principal Investigator: Noshir DaCosta, MD
Phone: 631-675-5075
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East Syracuse, New York 13057
Principal Investigator: Anthony Scalzo, MD
Phone: 315-472-7504
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Fort Myers, Florida 33901
Principal Investigator: Fadi Kayali, MD
Phone: 615-329-7613
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Fountain Valley, California 92708
Principal Investigator: Haresh Jhangiani, MD
Phone: 714-698-0303
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1562 Oppossumtown Pike
Frederick, Maryland 21702
Frederick, Maryland 21702
Principal Investigator: Brian O'Connor, MD
Phone: 301-668-7043
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Fresno, California 93720
Principal Investigator: Amardeep Aulakh, MD
Phone: 760-452-3909
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Fullerton, California 92835
Principal Investigator: David Park, MD
Phone: 714-992-3000
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Germantown, Tennessee 38138
Principal Investigator: Lee Schwartzberg, MD
Phone: 901-683-0055
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Goodyear, Arizona 85338
Principal Investigator: Cynthia Lynch, MD
Phone: 623-207-3126
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Grand Rapids, Michigan 49503
Principal Investigator: Amy Vander Woude, MD
Phone: 616-954-5550
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Hartford, Connecticut 06103
Principal Investigator: Stacy Nerenstone, MD
Phone: 860-972-5752
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Hattiesburg, Mississippi 39401
Principal Investigator: John Hrom, MD
Phone: 601-288-2495
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Hollywood, Florida
Principal Investigator: Aurelio Castrellon, MD
Phone: 954-844-9178
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Hot Springs, Arkansas 71913
Principal Investigator: Stephen Divers, MD
Phone: 501-624-7700
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Houston, Texas 77024
Principal Investigator: Michelina Cairo, MD
Phone: 713-467-1722
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Houston, Texas 77203
Principal Investigator: Julio Peguero, MD
Phone: 979-942-8898
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Houston, Texas 77024
Principal Investigator: Amir Rasheed, MD
Phone: 713-589-6400
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Indianapolis, Indiana 46254
Principal Investigator: Sridhar Bolla, MD
Phone: 317-462-1826
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Jackson, Mississippi 39202
Principal Investigator: Bobby Graham, MD
Phone: 601-355-2485
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Jacksonville, Florida 32256
Principal Investigator: Maria Valente, MD
Phone: 904-538-4488
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Johnson City, New York 13790
Principal Investigator: Ronald P Harris, MD
Phone: 607-763-8065
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100 Mercy Way
Joplin, Missouri 64804
Joplin, Missouri 64804
Principal Investigator: Samir Dalia, MD
Phone: 417-556-3074
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2316 East Meyer Boulevard
Kansas City, Missouri 64132
Kansas City, Missouri 64132
Principal Investigator: Stephanie Graff, MD
Phone: 816-276-4227
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Kennewick, Washington 99336
Principal Investigator: Ying Zhuo, MD
Phone: 509-783-4637
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Lakewood, Colorado 80228
Principal Investigator: Ling Ma, MD
Phone: 303-430-2700
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Lexington, Kentucky 40503
Principal Investigator: Amy Schell, MD
Phone: 859-639-8762
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8901 Carti Way
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Principal Investigator: Ryan Hall, MD
Phone: 501-906-3012
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757 Westwood Plaza
Los Angeles, California 90024
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: John Glaspy, MD
Phone: 310-794-3881
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Midlothian, Virginia 23114
Principal Investigator: William Irvin, MD
Phone: 804-594-3131
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Minneapolis, Minnesota 55407
Principal Investigator: Michaela Rsai, MD
Phone: 612-863-8716
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Nashville, Tennessee 37203
Principal Investigator: Denise Yardley, MD
Phone: 615-329-7613
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Andrew Seidman, MD
Phone: 646-888-5103
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Newnan, Georgia 30265
Principal Investigator: Ricardo Alverez, MD
Phone: 770-400-7080
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5900 Lake Wright Dr
Norfolk, Virginia 23502
Norfolk, Virginia 23502
(757) 466-8683
Principal Investigator: Michael Danso, MD
Phone: 757-466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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433 Southwest 10th Street
Ocala, Florida 34471
Ocala, Florida 34471
Principal Investigator: Anju Vasudevan, MD
Phone: 352-732-4938
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Oklahoma City, Oklahoma 73120
Principal Investigator: Vikki Canfield, MD
Phone: 405-751-4176
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Papillion, Nebraska 68046
Principal Investigator: Geetha Palaniappan, MD
Phone: 402-593-3141
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Paramus, New Jersey 07652
Principal Investigator: Thomas Rakowski, MD
Phone: 201-634-5439
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Philadelphia, Pennsylvania 19124
Principal Investigator: Sramila Aithal, MD
Phone: 215-537-3160
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300 Halket St.
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Principal Investigator: Vikram Gorantla, MD
Phone: 412-641-2357
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Plantation, Florida 33324
Principal Investigator: Carmen Calfa, MD
Phone: 954-210-1171
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Richmond, Virginia 23235
Principal Investigator: James Khatcheressian, MD
Phone: 804-287-3000
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Rockville, Maryland 20850
Principal Investigator: Cheryl Aylesworth, MD
Phone: 301-424-6231
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Cynthia Ma, MD
Phone: 314-362-7249
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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607 South New Ballas Road
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Principal Investigator: Bethany Sleckman, MD
Phone: 314-251-7061
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Saint Petersburg, Florida 33705
Principal Investigator: Gail Wright, MD
Phone: 727-216-1143
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7901 Frost Street
San Diego, California 92123
San Diego, California 92123
858-939-3400
Principal Investigator: Marie Shieh, MD
Phone: 858-939-5063
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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San Francisco, California 94115
Principal Investigator: Hope Rugo, MD
Phone: 415-353-7288
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San Luis Obispo, California 93401
Principal Investigator: Brian DiCarlo, MD
Phone: 805-543-5577
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Santa Ana, California 92705
Principal Investigator: Shlomit Ein-Gal, MD
Phone: 562-981-6101
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Seattle, Washington 98122
Principal Investigator: Kristine Rinn, MD
Phone: 206-386-6911
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Skokie, Illinois 60076
Principal Investigator: Ira Oliff, MD
Phone: 224-534-7580
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Sparta, New Jersey 07871
Principal Investigator: May Abdo-Matkiwsky, MD
Phone: 973-729-8801
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Stanford, California 94304
Principal Investigator: Mark Pegram, MD
Phone: 669-233-2816
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Tacoma, Washington 98405
Principal Investigator: Francis Senecal, MD
Phone: 253-200-3211
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Tallahassee, Florida 32308
Principal Investigator: Viralkumar Bhanderi, MD
Phone: 850-877-8166
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Tucson, Arizona 85704
Principal Investigator: Rachel Swart, MD
Phone: 520-531-8967
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Tulsa, Oklahoma 74146
Principal Investigator: Charles Taylor, MD
Phone: 918-505-3201
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721 Clinic Drive
Tyler, Texas 75701
Tyler, Texas 75701
Principal Investigator: Arielle Lee, MD
Phone: 903-592-6152
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1309 North Flagler Drive
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
Principal Investigator: Eric Harris, MD
Phone: 561-472-1696
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Whittier, California 90603
Principal Investigator: Richy Agajanian, MD
Phone: 562-693-4477
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