Metastatic Breast CancerPhase 3NCT05283837
A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)
A Phase 3 study testing Pertuzumab (ZRC-3277) and Pertuzumab (Perjeta®) in people with Metastatic Breast Cancer, run by Zydus Lifesciences Limited at 1 site in India.
Trial summary
The purpose of this study is to compare the efficacy, safety, pharmacokinetic, and immunogenicity of Pertuzumab (Test, Cadila Healthcare Ltd.,) plus Trastuzumab and Docetaxel versus Pertuzumab (Reference, Genentech Inc.,) plus Trastuzumab and Docetaxel treatment in previously untreated patients with HER2 positive MBC. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Pertuzumab (ZRC-3277) and Pertuzumab (Perjeta®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteIndia
- Study dates
- 26 Sep 2022to 6 Sep 2023
- Phase
- Phase 3
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients 18 to 65 years of age (both inclusive).
- Patient with pathologically (histologically or cytologically) confirmed, adenocarcino-ma metastatic breast cancer and candidate for chemotherapy. Note: Patients with de-novo Stage IV disease are eligible.
- With at least one measurable metastatic target lesion (based on RECIST criteria, ver-sion 1.1).
- Documentation of following prior to randomization:
- Documentation of HER2 gene amplification by fluorescent in situ hybridiza-tion (FISH); as defined by a ratio >2.0) OR documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) (estrogen receptor/progesterone receptor positive subjects may be enrolled if they are HER2 positive) prior to randomization, see Section 6.4 for detailed criteria)
- Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
Show all 10Show fewer
- Left ventricular ejection fraction (LVEF) of ≥ 50% at baseline (within 42 days of ran-domization) as measured by echocardiography (ECHO) or multiple gated acquisition (MUGA). Note: ECHO is the preferred method. If the patient is randomized, the same method of LVEF assessment (i.e., ECHO or MUGA) must be used throughout the study and it should preferably be obtained at the same institution and preferably by the same assessor)
- Patient able to understand and willing to give the informed consent and able to com-ply with the requirements of the study protocol.
- A woman of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin [β-hCG]) at screening and urine β-hCG test at random-ization.
- Woman of child-bearing potential must agree to use adequate contraceptive methods that is highly effective (with a failure rate of <1% per year), with low user dependen-cy when used consistently and correctly, during the intervention period and for at least 7 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of 7 months. The investigator should evaluate the effectiveness of the contraceptive meth-od in relationship to the first dose of study intervention.
Who cannot join
- History of anticancer therapy for MBC, with the exception of single prior hormonal regimen for MBC, which must be stopped prior to randomization.
- Note 1: Anticancer therapy for MBC includes any epidermal growth factor receptor or anti-HER2 agents or vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen for MBC Note 2: Single prior hormonal regimen for MBC may include more than one hormo-nal therapy. If a patient is switched to a different hormonal therapy because of dis-ease progression, this will be counted as two regimens, and the patient will not be eli-gible for the study. If a patient is switched to a different hormonal therapy for reasons other than disease progression (e.g., toxicity or local standard practice), this will be counted as single regimen.
- History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of < 12 months.
- History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant set-ting.
- Patients with CNS metastases, except for treated asymptomatic CNS metastases, pro-vided all of the following criteria are met:
- Only supra-tentorial metastases allowed (i.e., no metastases to midbrain, pons, medulla, or spinal cord)
Show all 44Show fewer
- No evidence of interim progression or hemorrhage after completion of CNS-directed therapy
- No ongoing requirement for corticosteroids as therapy for CNS disease (anti-convulsants at a stable dose are allowed)
- No stereotactic radiation within 14 days or whole-brain radiation within 28 days prior to randomization
- Leptomeningeal disease (i.e. carcinomatous meningitis)
- History of persistent Grade ≥ 2 hematologic toxicity resulting from previous neoad-juvant or adjuvant therapy (all grades based on National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 5.0 [NCI CTCAE v 5.0]).
- Current peripheral neuropathy of NCI-CTCAE, Version 5.0, Grade ≥ 3 at randomiza-tion.
- Have a history of congestive heart failure (CHF) of any New York Heart Association (NYHA) criterion, or serious cardiac arrhythmia requiring treatment (except for atrial fibrillation, paroxysmal supraventricular tachycardia).
- History of myocardial infarction within 6 months before randomization.
- Current uncontrolled hypertension (systolic blood pressure >150 mmHg and/or dias-tolic blood pressure >100 mmHg), or unstable angina.
- Current dyspnea at rest due to complications of advanced malignancy or other diseas-es that require continuous oxygen therapy.
- History of other malignancy within the previous 5 years, except for carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been previously treated with curative intent.
- History of exposure to the following cumulative doses of anthracyclines:
- doxorubicin or liposomal doxorubicin > 360 mg/m2
- epirubicin > 720 mg/m2
- mitoxantrone > 120 mg/m2 and idarubicin > 90 mg/m2
- Other (e.g., liposomal doxorubicin or other anthracycline > the equivalent of 360 mg/m2 of doxorubicin)
- If more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin.
- Have received stem-cell support for chemotherapy.
- Have a history of hypersensitivity to the Pertuzumab or to drugs with similar chemical structures, or to any of the excipients, or to murine proteins.
- Have a history of severe hypersensitivity reaction to Trastuzumab and Docetaxel, or to any of the excipients.
- Inadequate organ function, evidenced by the following laboratory results within 28 days prior to randomization:
- Hemoglobin level < 9 g/dL
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 3.0 x upper limit of normal (ULN) (>5 x ULN in patients with liver metasta-ses)
- AST (SGOT) or ALT (SGPT) > 1.5 × ULN with concurrent serum alkaline phosphatase > 2.5 × ULN (unless bone metastases are present)
- Absolute neutrophil count < 1,500 cells/mm3
- Total serum bilirubin >1.5 x ULN
- Serum creatinine > 2.0 mg/dL or 177 μmol/L
- Have received treatment with any other investigational drug in the last 30 days before study entry, or within less than five half-lives after receiving the previous investiga-tional drug.
- Receipt of IV antibiotics for infection within 14 days of randomization.
- Current chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
- History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.
- Pregnant or a nursing mother.
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment.
- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascu-lar, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone frac-tures).
- Have a history or suspicion of unreliability, poor cooperation or non-compliance with medical treatment or any other medical or psychiatric condition that could compro-mise study participation.
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 1 year before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at Screening.
- Have any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallel Study to Evaluate the Efficacy and Safety of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) With Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Patients With HER2 Positive Metastatic Breast Cancer
The purpose of this study is to compare the efficacy, safety, pharmacokinetic, and immunogenicity of Pertuzumab (Test, Cadila Healthcare Ltd.,) plus Trastuzumab and Docetaxel versus Pertuzumab (Reference, Genentech Inc.,) plus Trastuzumab and Docetaxel treatment in previously untreated patients with HER2 positive MBC.
Read the detailed description
Breast cancer is the second most common cancer worldwide and the fifth cause of death from cancer overall (522,000 deaths) and it is the most frequent cause of cancer death in women in less developed regions.In developed countries between 6 and 10 % of women will have metastatic disease when diagnosed with breast cancer ; in developing countries this percentage can reach 60 %. Depending on initial stage, tumor biology, and type of treatment scheme received, between 30 and 50 % of women with early breast cancer will relapse. Pertuzumab targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2) and, thereby, blocks ligand-dependent heterodimerization of HER2 with other HER family members, including EGFR, HER3, and HER4. As a result, Pertuzumab inhibits ligandinitiated intracellular signaling through two major signal pathways, mitogenactivated protein (MAP) kinase, and phosphoinositide 3-kinase (PI3K). Inhibition of these signaling pathways can result in cell growth arrest and apoptosis, respectively. In addition, Pertuzumab mediates antibody-dependent cellmediated cytotoxicity (ADCC). Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular 286 dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein 287 (HER2). Pertuzumab inhibits ligandinitiated intracellular signaling through two 299 major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase 300 (PI3K). Hence we have planned this study which is a Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallel study to Evaluate the Efficacy and Safety of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) with Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Previously Untreated Patients with HER2 Positive Metastatic Breast Cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Pertuzumab (ZRC-3277), Pertuzumab (Perjeta®)
- Keywords
- HER2 Positive, PERTUZUMAB, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pertuzumab (ZRC-3277)Biological
Pertuzumab in combination with Trastuzumab and Docetaxel will be administered via intravenous (IV) infusion every 3 weeks for 06 cycles.
Pertuzumab (Perjeta®)Biological
Pertuzumab in combination with Trastuzumab and Docetaxel will be administered via intravenous (IV) infusion every 3 weeks for 06 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) | Experimental | Pertuzumab (ZRC-3277) will be administered at a loading dose of 840 mg via IV infusion over 60 minutes (± 10 minutes) in Cycle 1 followed by 420 mg via IV infusion over 30 to 60 minutes in subsequent cycles then be given every 3 weeks, starting 3 weeks later till cycle 6. Receives: Biological: Pertuzumab (ZRC-3277) |
| Pertuzumab (Perjeta®, a product of Genentech, Inc.,) | Active comparator | Perjeta® will be administered at a loading dose of 840 mg via IV infusion over 60 minutes (± 10 minutes) in Cycle 1 followed by 420 mg via IV infusion over 30 to 60 minutes in subsequent cycles then be given every 3 weeks, starting 3 weeks later till cycle 6. Receives: Biological: Pertuzumab (Perjeta®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at day 127 from baseline
Measured: from time of First treatment to Day 127
Secondary outcomes (5)
Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)
Blood samples will be withdrawn for the evaluation of pharmacokinetic parameter.
Measured: During Cycle 1(each cycle is of 21 days)
The area under the serum concentration versus time curve from time zero to infinity (AUC0-inf)
Blood samples will be withdrawn for the evaluation of pharmacokinetic parameter.
Measured: During Cycle 1(each cycle is 21 days)
maximum measured serum concentration observed after a single dose at cycle 1 (Cmax)
Blood samples will be withdrawn for the evaluation of pharmacokinetic parameter.
Measured: During Cycle 1(each cycle is 21 days)
Time of the maximum measured serum concentration (Tmax)
Blood samples will be withdrawn for the evaluation of pharmacokinetic parameter.
Measured: During Cycle 1(each cycle is 21 days)
serum trough concentration of ZRC-3277 (Pre-Dose)
Blood samples will be withdrawn for the evaluation of pharmacokinetic parameter.
Measured: Pre-dose on Day 1 of Cycle 1,2,3,4,5 and 6. (each cycle is of 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start26 Sep 2022
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Multi-center, Comparative, Double-blind, Parallel study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Deven Parmar, MD, Study director, Zydus Lifesciences Ltd (formerly Known as Cadila Healthcare Ltd)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283837
- Sponsor's protocol ID
- PERT.21.001
- Status last verified
- Feb 2022
- First submitted
- 26 Feb 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallel Study to Evaluate the Efficacy and Safety of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) With Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Patients With HER2 Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05283837
- Acronym / sponsor ID
- PERT.21.001
- Conditions
- Metastatic Breast Cancer
- Keywords
- HER2 Positive, PERTUZUMAB, Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy, safety, pharmacokinetic, and immunogenicity of Pertuzumab (Test, Cadila Healthcare Ltd.,) plus Trastuzumab and Docetaxel versus Pertuzumab (Reference, Genentech Inc.,) plus Trastuzumab and Docetaxel treatment in previously untreated patients with HER2 positive MBC.
Detailed description
Breast cancer is the second most common cancer worldwide and the fifth cause of death from cancer overall (522,000 deaths) and it is the most frequent cause of cancer death in women in less developed regions.In developed countries between 6 and 10 % of women will have metastatic disease when diagnosed with breast cancer ; in developing countries this percentage can reach 60 %. Depending on initial stage, tumor biology, and type of treatment scheme received, between 30 and 50 % of women with early breast cancer will relapse. Pertuzumab targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2) and, thereby, blocks ligand-dependent heterodimerization of HER2 with other HER family members, including EGFR, HER3, and HER4. As a result, Pertuzumab inhibits ligandinitiated intracellular signaling through two major signal pathways, mitogenactivated protein (MAP) kinase, and phosphoinositide 3-kinase (PI3K). Inhibition of these signaling pathways can result in cell growth arrest and apoptosis, respectively. In addition, Pertuzumab mediates antibody-dependent cellmediated cytotoxicity (ADCC). Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular 286 dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein 287 (HER2). Pertuzumab inhibits ligandinitiated intracellular signaling through two 299 major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase 300 (PI3K). Hence we have planned this study which is a Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallel study to Evaluate the Efficacy and Safety of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) with Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Previously Untreated Patients with HER2 Positive Metastatic Breast Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Multi-center, Comparative, Double-blind, Parallel study
| Arm | Type | Receives |
|---|---|---|
| Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) | Experimental | Biological: Pertuzumab (ZRC-3277)Pertuzumab (ZRC-3277) will be administered at a loading dose of 840 mg via IV infusion over 60 minutes (± 10 minutes) in Cycle 1 followed by 420 mg via IV infusion over 30 to 60 minutes in subsequent cycles then be given every 3 weeks, starting 3 weeks later till cycle 6. |
| Pertuzumab (Perjeta®, a product of Genentech, Inc.,) | Active comparator | Biological: Pertuzumab (Perjeta®)Perjeta® will be administered at a loading dose of 840 mg via IV infusion over 60 minutes (± 10 minutes) in Cycle 1 followed by 420 mg via IV infusion over 30 to 60 minutes in subsequent cycles then be given every 3 weeks, starting 3 weeks later till cycle 6. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients 18 to 65 years of age (both inclusive).
- Patient with pathologically (histologically or cytologically) confirmed, adenocarcino-ma metastatic breast cancer and candidate for chemotherapy. Note: Patients with de-novo Stage IV disease are eligible.
- With at least one measurable metastatic target lesion (based on RECIST criteria, ver-sion 1.1).
- Documentation of following prior to randomization:
- Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (44 listed)
- History of anticancer therapy for MBC, with the exception of single prior hormonal regimen for MBC, which must be stopped prior to randomization.
- Note 1: Anticancer therapy for MBC includes any epidermal growth factor receptor or anti-HER2 agents or vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen for MBC Note 2: Single prior hormonal regimen for MBC may include more than one hormo-nal therapy. If a patient is switched to a different hormonal therapy because of dis-ease progression, this will be counted as two regimens, and the patient will not be eli-gible for the study. If a patient is switched to a different hormonal therapy for reasons other than disease progression (e.g., toxicity or local standard practice), this will be counted as single regimen.
- History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of < 12 months.
- History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant set-ting.
- Patients with CNS metastases, except for treated asymptomatic CNS metastases, pro-vided all of the following criteria are met:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pertuzumab (ZRC-3277)Pertuzumab in combination with Trastuzumab and Docetaxel will be administered via intravenous (IV) infusion every 3 weeks for 06 cycles. | Biological | Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) |
| Pertuzumab (Perjeta®)Pertuzumab in combination with Trastuzumab and Docetaxel will be administered via intravenous (IV) infusion every 3 weeks for 06 cycles. | Biological | Pertuzumab (Perjeta®, a product of Genentech, Inc.,) |
Primary outcome
Compare Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at day 127 from baseline
Time frame: from time of First treatment to Day 127
5 secondary outcomes
Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)
Time frame: During Cycle 1(each cycle is of 21 days)
The area under the serum concentration versus time curve from time zero to infinity (AUC0-inf)
Time frame: During Cycle 1(each cycle is 21 days)
maximum measured serum concentration observed after a single dose at cycle 1 (Cmax)
Time frame: During Cycle 1(each cycle is 21 days)
Time of the maximum measured serum concentration (Tmax)
Time frame: During Cycle 1(each cycle is 21 days)
serum trough concentration of ZRC-3277 (Pre-Dose)
Time frame: Pre-dose on Day 1 of Cycle 1,2,3,4,5 and 6. (each cycle is of 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Deven Parmar, MD study director
Zydus Lifesciences Ltd (formerly Known as Cadila Healthcare Ltd)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pertuzumab (ZRC-3277) and Pertuzumab (Perjeta®) in people with Metastatic Breast Cancer, run by Zydus Lifesciences Limited at 1 site in India.
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 10 inclusion and 44 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: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at day 127 from baseline (time frame: from time of First treatment to Day 127). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2024.