Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment
Interventional
Phase 3
Jazz Pharmaceuticals (Voir sur ClinicalTrials)
août 2024
novembre 2031
05 août 2025
The efficacy and safety of zanidatamab in combination with physician's choice of
chemotherapy compared with trastuzumab in combination with physician's choice of
chemotherapy will be evaluated for the treatment of participants with metastatic
HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd
treatment.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP HM Hopital de La Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Centre François Baclesse - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille Cedex - France | Contact (sur clinicalTrials) | ||||
| ICANS - Institut de cancérologie Strasbourg Europe - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux Cedex - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Oncopôle Claudius Regaud Pharmacie - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Pharmacie Centre de Cancerologie de la Sarthe - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Pharmacie ICM Val d'Aurelle - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Participants are eligible to be included in the study only if all of the following
criteria apply:
1. Is 18 years of age or of the legal adult age per local standard at the time of
signing the informed consent.
2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP
Guidelines as evaluated by a central laboratory
3. Participants with unresectable or metastatic HER2 positive breast cancer who have
progressed on, or are intolerant to, previous T-DXd treatment.
4. Has measurable disease per RECIST version 1.1.
5. Is eligible to receive one of the chemotherapy options listed in the physician's
choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine).
6. Participants with history of treated or clinically inactive CNS metastases are
eligible as specified in the protocol.
7. Has a life expectancy of at least 6 months, in the opinion of the investigator.
8. Has adequate hematologic parameters as defined in the protocol.
9. Has adequate hepatic function as specified in the protocol.
10. Has creatinine clearance ≥ 30 mL/minute as calculated per local institutional
guidelines.
11. Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4
weeks before the first dose of study intervention.
12. Has ECOG performance status of 0 or 1.
13. Participant agrees to the following based on sex assigned at birth.
1. Male participants:
Male participants are eligible to participate if they agree to the following
during the study intervention period and for at least 5 months after the last
dose of study intervention or the contraception period for the combination
chemotherapy of choice per local guidance/standard practice, whichever is
longer:
- Refrain from donating fresh unwashed semen.
- Use contraception as follows as specified in the protocol
2. Female participants:
- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and one of the following conditions applies:
- Is a women of nonchildbearing potential OR
- Is a woman of childbearing potential (WOCBP) and using a
contraceptive method that is highly effective (with a failure rate of
< 1% per year), with low user dependency during the study
intervention period and for at least 5 months after the last dose of
study intervention or the contraception period for the combination
chemotherapy of choice per local guidance/standard practice,
whichever is longer.
- A WOCBP must have a negative highly sensitive pregnancy test (urine or
serum as required by local regulations) within 3 days before the first
dose of study intervention.
- Additional requirements for pregnancy testing during and after study
intervention are provided in the protocol.
- The investigator is responsible for review of medical history, menstrual
history, and recent sexual activity to decrease the risk for inclusion of
a woman with an early undetected pregnancy.
14. Is capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent form and in the
protocol.
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Has known or suspected leptomeningeal disease.
2. Has uncontrolled or significant cardiovascular disease.
3. Has toxicity related to prior cancer therapy that has not resolved to ≤ Grade 1,
with exceptions as stated in the protocol.
4. Has uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
5. Has known HIV infection.
6. Has active hepatitis B or C infection.
7. Has an active SARS-CoV-2 infection. Participants with prior infection that has
resolved per local institutions' requirements and screening guidance are eligible.
8. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to
recombinant proteins or excipients in the drug formulation of zanidatamab.
9. Is unable to receive trastuzumab treatment due to medical contraindications.
10. Has any serious underlying medical or psychiatric condition that would impair the
ability of the participant to receive or tolerate the planned treatment at the
investigational site.
11. Has any condition that would prevent treatment with the physician's choice of
chemotherapy.
12. Has any issue or condition that in the opinion of the investigator would
contraindicate the participant's participation in the study or confound the results
of the study.
Prior/Concomitant Therapy
13. Has a history of prior allogeneic bone marrow, stem cell, or solid organ
transplantation.
14. Was treated with any local or systemic antineoplastic therapy (including hormonal
therapies for breast cancer) or any investigational therapy within 4 weeks or 5
half-lives (whichever is longer) prior to randomization.
15. Has a history of trauma or major surgery within 4 weeks prior to randomization.
Other Exclusions
16. Has a known hypersensitivity to any components of the study drugs, including
chemotherapy.
17. Female participants who are breastfeeding or pregnant, and female and male
participants planning a pregnancy.
criteria apply:
1. Is 18 years of age or of the legal adult age per local standard at the time of
signing the informed consent.
2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP
Guidelines as evaluated by a central laboratory
3. Participants with unresectable or metastatic HER2 positive breast cancer who have
progressed on, or are intolerant to, previous T-DXd treatment.
4. Has measurable disease per RECIST version 1.1.
5. Is eligible to receive one of the chemotherapy options listed in the physician's
choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine).
6. Participants with history of treated or clinically inactive CNS metastases are
eligible as specified in the protocol.
7. Has a life expectancy of at least 6 months, in the opinion of the investigator.
8. Has adequate hematologic parameters as defined in the protocol.
9. Has adequate hepatic function as specified in the protocol.
10. Has creatinine clearance ≥ 30 mL/minute as calculated per local institutional
guidelines.
11. Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4
weeks before the first dose of study intervention.
12. Has ECOG performance status of 0 or 1.
13. Participant agrees to the following based on sex assigned at birth.
1. Male participants:
Male participants are eligible to participate if they agree to the following
during the study intervention period and for at least 5 months after the last
dose of study intervention or the contraception period for the combination
chemotherapy of choice per local guidance/standard practice, whichever is
longer:
- Refrain from donating fresh unwashed semen.
- Use contraception as follows as specified in the protocol
2. Female participants:
- A female participant is eligible to participate if she is not pregnant or
breastfeeding, and one of the following conditions applies:
- Is a women of nonchildbearing potential OR
- Is a woman of childbearing potential (WOCBP) and using a
contraceptive method that is highly effective (with a failure rate of
< 1% per year), with low user dependency during the study
intervention period and for at least 5 months after the last dose of
study intervention or the contraception period for the combination
chemotherapy of choice per local guidance/standard practice,
whichever is longer.
- A WOCBP must have a negative highly sensitive pregnancy test (urine or
serum as required by local regulations) within 3 days before the first
dose of study intervention.
- Additional requirements for pregnancy testing during and after study
intervention are provided in the protocol.
- The investigator is responsible for review of medical history, menstrual
history, and recent sexual activity to decrease the risk for inclusion of
a woman with an early undetected pregnancy.
14. Is capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent form and in the
protocol.
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Has known or suspected leptomeningeal disease.
2. Has uncontrolled or significant cardiovascular disease.
3. Has toxicity related to prior cancer therapy that has not resolved to ≤ Grade 1,
with exceptions as stated in the protocol.
4. Has uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
5. Has known HIV infection.
6. Has active hepatitis B or C infection.
7. Has an active SARS-CoV-2 infection. Participants with prior infection that has
resolved per local institutions' requirements and screening guidance are eligible.
8. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to
recombinant proteins or excipients in the drug formulation of zanidatamab.
9. Is unable to receive trastuzumab treatment due to medical contraindications.
10. Has any serious underlying medical or psychiatric condition that would impair the
ability of the participant to receive or tolerate the planned treatment at the
investigational site.
11. Has any condition that would prevent treatment with the physician's choice of
chemotherapy.
12. Has any issue or condition that in the opinion of the investigator would
contraindicate the participant's participation in the study or confound the results
of the study.
Prior/Concomitant Therapy
13. Has a history of prior allogeneic bone marrow, stem cell, or solid organ
transplantation.
14. Was treated with any local or systemic antineoplastic therapy (including hormonal
therapies for breast cancer) or any investigational therapy within 4 weeks or 5
half-lives (whichever is longer) prior to randomization.
15. Has a history of trauma or major surgery within 4 weeks prior to randomization.
Other Exclusions
16. Has a known hypersensitivity to any components of the study drugs, including
chemotherapy.
17. Female participants who are breastfeeding or pregnant, and female and male
participants planning a pregnancy.