Premenopausal HR+/HER2- Metastatic Breast CancerPhase 2Young-PALETTANCT04819243
PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study
A Phase 2 study testing Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab and Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, in people with Premenopausal HR+/HER2- Metastatic Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is a prospective, two-arm, randomized phase II study of talazoparib versus talazoparib plus atezolizumab in ER+ premeonopausal women with metastatic breast cancer harboring HRD scar 1st line treatment: GnRH agonist + Aromatase Inhibitor(AI) + Palbociclib 28 days after the last treatment of 1st line… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Premenopausal HR+/HER2- Metastatic Breast Cancer
- What is being tested?
- Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab and Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib,
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Aug 2021to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For subjects who were enrolled in the 1L treatment part of the study, inclusion criteria 1)-4) should be met.
- For subjects who were not enrolled in the 1L treatment part of the study, all of the following inclusion criteria should be met prior to the study enrollment.
- ECOG performance status 0 - 2
- Adequate bone marrow function (≥ANC 1,500/ul, ≥platelet 100,000/ul, ≥Hemoglobin 9.0 g/dl)
- Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 60 ml/min)
- Adequate liver function (≤ serum bilirubin 2.0 mg/dl, ≤ AST/ALT x 3 upper normal limit) If the subject has liver metastasis, AST/ALT x 5 upper normal limit is acceptable
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- Histologically confirmed metastatic or locally advanced breast cancer that is not amenable to curative surgery, with or without measurable disease. Patients who have stage IV breast cancer at diagnosis (de novo) or have progressed on distant metastatic sites after curative surgery are eligible.
- Prior treatment with endocrine-based therapy + CDK4/6 inhibitor for metastatic or inoperable locally advanced breast cancer. Allowed endocrine-based therapy is as below:
- Aromatase Inhibitor B. For subjects who had disease progression during or after the adjuvant aromatase inhibitor therapy, fulvestrant C. Up to one line of chemotherapy for metastatic or inoperable locally advanced breast cancer is allowed except for platinum based chemotherapy.
- Confirmed germline pathogenic BRCA1 and/or BRCA2 mutation or 35 HRD-related gene alterations (see Appendix 16.5)
- age > 19 years
- Patient has HER2 IHC0, IHC1+, or ICH2+/ISH-, as determined according to ASCO/CAP guidelines breast cancer
- Patient has ER positive and/or PgR positive according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as 1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally
- Female patients should be premenopausal. Premenopausal status is defined as either:
- Patient had last menstrual period within the last 12 months B. If on tamoxifen within the past 3 months, with a plasma estradiol ≥10 pg/mL and FSH ≤40 IU/l or in the premenopausal range, according to local laboratory definition C. in case of chemotherapy induced amenorrhea, with a plasma estradiol ≥10 pg/mL) and/or FSH ≤40IU/l or in the premenopausal range according to local laboratory definition.
- If the subject started ovarian function suppression, above A-C criteria should be met prior to starting ovarian function suppression.
- No possibility of pregnancy and/or urine or serum beta-HCG negative
- Patients may continue an ongoing bisphosphonate or denosumab therapy.
- Patients who agreed to use an effective contraception method or have no childbearing potential
- Written informed consent
- Patients who agreed to offer tumor tissue and blood for biomarker analysis
Who cannot join
- Postmenopausal women except women who had BSO (Bilateral Salpingo Oophorectomy)
- Serious uncontrolled intercurrent infections within 4 weeks prior to Cycle 1 Day 1 of 1st Treatment
- Serious intercurrent medical or psychiatric illness, including active cardiac disease
- Participants who are pregnant or breast feeding or intending to become pregnant during the study or within 5 months after the final dose of study treatments.
- Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or favorable thyroid papillary carcinoma(follicular thyroid cancer, including PTC) or other malignancy treated at least 5 years previously with no evidence of recurrence)
- Patients has received previous endocrine treatments in the metastatic setting (Except tamoxifen only ± GnRH agonist)
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- Patients has received previous aromatase inhibitor (less than 1 year after the last dose)
- Patients has received previous treatment with CDK 4/6 inhibitors, OR PARP1 inhibitors, OR immune check point inhibitors (less than 1 year after the last dose)
- Known brain metastases, symptomatic or asymptomatic
- History of clinically significant liver disease, current alcohol abuse or known active infection
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Prior allogeneic stem cell or solid organ transplantation
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computerised tomography (CT) scan
- Active tuberculosis
- Receipt of a live, attenuated vaccine within 4 weeks prior to Cycle 1 Day 1 of 1st Treatment or anticipation that a live, attenuated vaccine will be required during atezolizumab treatment or within 5 months after the last dose of atezolizumab
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or interlukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to Cycle 1 Day 1 of 1st Treatment
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, mycophenolate, and anti-tumour necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1 Day 1 of 1st Treatment, or anticipated requirement for systemic immunosuppressive medications during the trial
- For subjects who participate only in the 2L treatment part of the study, all exclusion criteria should be met prior to study enrollment.
- Postmenopausal women except women who had BSO (Bilateral Salpingo Oophorectomy)
- Serious intercurrent medical or psychiatric illness, including active cardiac disease
- Participants who are pregnant or breast feeding or intending to become pregnant during the study or within 5 months after the final dose of study treatments.
- Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or favorable thyroid papillary carcinoma(follicular thyroid cancer, including PTC) or other malignancy treated at least 5 years previously with no evidence of recurrence)
- Patients who have previously received PARP1 inhibitors OR immune check point inhibitors
- Patients who have previously received platinum based chemotherapy or two or more lines of chemotherapy for metastatic or inoperable locally advanced breast cancer
- Known brain metastases, symptomatic or asymptomatic
- History of clinically significant liver disease, current alcohol abuse or known active infection
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Prior allogeneic stem cell or solid organ transplantation
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computerised tomography (CT) scan
- Active tuberculosis
- Receipt of a live, attenuated vaccine within 4 weeks prior to Cycle 1 Day 1 of 1st Treatment or anticipation that a live, attenuated vaccine will be required during atezolizumab treatment or within 5 months after the last dose of atezolizumab
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or interlukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to Cycle 1 Day 1 of 1st Treatment
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, mycophenolate, and anti-tumour necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1 Day 1 of 1st Treatment, or anticipated requirement for systemic immunosuppressive medications during the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung medical Center
Seoul, Gannam-gu, 06351
Yeon Hee Park, phD, 82-2-3410-1780, yeonh.park@samsung.com
mieun Kim, CRA, 82-2-2148-7664, mieun2728.kim@samsung.com
About this study
Official title: Randomized Phase II Study of Talazoparib Versus Talazoparib Plus Atezolizumab After Palbociclib Combination Endocrine Therapy for Patients with Premenopausal HR+/HER2- Metastatic Breast Cancer Harboring HRD Scar
This study is a prospective, two-arm, randomized phase II study of talazoparib versus talazoparib plus atezolizumab in ER+ premeonopausal women with metastatic breast cancer harboring HRD scar
1st line treatment: GnRH agonist + Aromatase Inhibitor(AI) + Palbociclib 28 days after the last treatment of 1st line treatment(., randomization for 2nd line treatment is conducte to arm A(Talazoparib+Atezolizumab) and arm B(Talazoparib monotherapy)
Read the detailed description
- st line treatment
- Palbociclib: A capsule will be administered once a day for 21 days and rest for 7 days (1cycle=28days)
- AI treatment: D1~28 days. Take once a day. Prescribed according to local prescribe guideline.
- GnRH agonist: At D1 for every cycle with 4 week (+3days) interval via subcutaneous injection. (or ET + CDK4/6 inhibitors + GnRH agonist)
- nd line treatment
28 days after the last treatment of 1st line treatment, randomization for 2nd line treatment is conducte to arm A(Talazoparib+Atezolizumab) and arm B(Talazoparib monotherapy)
- Talazoparib: Take orally once a day at the same time
- Atezolizumab: 1,200mg, at D1 of each cycle. Applicable for arm A only.
- Being tested
- Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab, Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, AtezolizumabDrug
- Palbociclib 125mg
- AI
- GnRH agonist (or ET + CDK4/6 inhibitors + GnRH agonist)
- Talazoparib
- Atezolizumab
Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib,Drug
- Palbociclib 125mg
- AI
- GnRH agonist (or ET + CDK4/6 inhibitors + GnRH agonist)
- Talazoparib
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab+Talazoparib | Experimental | 1. st line treatment
* Palbociclib 125mg po D1-21
* AI : Prescribed as per local guideline
* GnRH agonist: Prescribed as per local guideline (or ET + CDK4/6 inhibitors + GnRH agonist)
2. nd line treatment
* Talazoparib 1mg po
* Atezolizumab 1200mg IV (3week) Receives: Drug: Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab |
| Talazoparib | Experimental | 1. st line treatment
* Palbociclib 125mg po D1-21
* AI : Prescribed as per local guideline
* GnRH agonist: Prescribed as per local guideline (or ET + CDK4/6 inhibitors + GnRH agonist)
2. nd line treatment - Talazoparib 1mg po Receives: Drug: Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, |
What is being measured
The primary outcome is the main question the study is designed to answer.
2nd Progression free survival (PFS)
To assess measures of clinical efficacy. It is a measure of the period of survival without disease progression by Kaplan-Meier method.
Measured: The time until the time of the first event(the progression of a recorded disease of breast cancer or death from all causes) in 2nd line treatment. Up to 72months
Secondary outcomes (4)
Composite PFS (1st PFS + 2nd PFS)
To assess measures of clinical efficacy. It is a measure of the period of survival without disease progression by Kaplan-Meier method.
Measured: The time from the day 1 of first therapy to the time of first event (documented disease progression of breast cancer or death due to any cause) in 1st and 2nd line therapy. Up to 72months
Overall survival (OS)
To assess secondary measures of clinical efficacy.
Measured: Survival will be measured as the time from the randomization occurs after Progression of 1st line to the date of death. Up to 72months
Toxicity assessment
Clinical and laboratory toxicity/symptomatology will be graded based on the NCIC CTG v5.0
Measured: from the date of informed consent signature to 28 days after last drug administration
Quality of Life (QoL)
The QoL will be evaluated using EQ5D
Measured: from the date of informed consent signature to 28 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start25 Aug 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenopausal HR+/HER2- Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819243
- Sponsor's protocol ID
- 2021-01-075
- Acronym
- Young-PALETTA
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2021
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Talazoparib Versus Talazoparib Plus Atezolizumab After Palbociclib Combination Endocrine Therapy for Patients with Premenopausal HR+/HER2- Metastatic Breast Cancer Harboring HRD Scar
- ClinicalTrials.gov ID
- NCT04819243
- Acronym / sponsor ID
- Young-PALETTA / 2021-01-075
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Mar 2021 (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.
This study is a prospective, two-arm, randomized phase II study of talazoparib versus talazoparib plus atezolizumab in ER+ premeonopausal women with metastatic breast cancer harboring HRD scar
1st line treatment: GnRH agonist + Aromatase Inhibitor(AI) + Palbociclib 28 days after the last treatment of 1st line treatment(., randomization for 2nd line treatment is conducte to arm A(Talazoparib+Atezolizumab) and arm B(Talazoparib monotherapy)
Detailed description
- st line treatment
- Palbociclib: A capsule will be administered once a day for 21 days and rest for 7 days (1cycle=28days)
- AI treatment: D1~28 days. Take once a day. Prescribed according to local prescribe guideline.
- GnRH agonist: At D1 for every cycle with 4 week (+3days) interval via subcutaneous injection. (or ET + CDK4/6 inhibitors + GnRH agonist)
- nd line treatment
28 days after the last treatment of 1st line treatment, randomization for 2nd line treatment is conducte to arm A(Talazoparib+Atezolizumab) and arm B(Talazoparib monotherapy)
- Talazoparib: Take orally once a day at the same time
- Atezolizumab: 1,200mg, at D1 of each cycle. Applicable for arm A only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab+Talazoparib | Experimental | Drug: Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab1. st line treatment * Palbociclib 125mg po D1-21 * AI : Prescribed as per local guideline * GnRH agonist: Prescribed as per local guideline (or ET + CDK4/6 inhibitors + GnRH agonist) 2. nd line treatment * Talazoparib 1mg po * Atezolizumab 1200mg IV (3week) |
| Talazoparib | Experimental | Drug: Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib,1. st line treatment * Palbociclib 125mg po D1-21 * AI : Prescribed as per local guideline * GnRH agonist: Prescribed as per local guideline (or ET + CDK4/6 inhibitors + GnRH agonist) 2. nd line treatment - Talazoparib 1mg po |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
Key exclusion criteria (33 listed)
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 |
|---|---|---|
| Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab* Palbociclib 125mg * AI * GnRH agonist (or ET + CDK4/6 inhibitors + GnRH agonist) * Talazoparib * Atezolizumab | Drug | Atezolizumab+Talazoparib |
| Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib,* Palbociclib 125mg * AI * GnRH agonist (or ET + CDK4/6 inhibitors + GnRH agonist) * Talazoparib | Drug | Talazoparib |
Primary outcome
2nd Progression free survival (PFS)
Time frame: The time until the time of the first event(the progression of a recorded disease of breast cancer or death from all causes) in 2nd line treatment. Up to 72months
To assess measures of clinical efficacy. It is a measure of the period of survival without disease progression by Kaplan-Meier method.
4 secondary outcomes
Composite PFS (1st PFS + 2nd PFS)
Time frame: The time from the day 1 of first therapy to the time of first event (documented disease progression of breast cancer or death due to any cause) in 1st and 2nd line therapy. Up to 72months
Overall survival (OS)
Time frame: Survival will be measured as the time from the randomization occurs after Progression of 1st line to the date of death. Up to 72months
Toxicity assessment
Time frame: from the date of informed consent signature to 28 days after last drug administration
Quality of Life (QoL)
Time frame: from the date of informed consent signature to 28 days after last drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab and Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, in people with Premenopausal HR+/HER2- Metastatic Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 21 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 3 Jan 2025. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeon Hee Park, phD (+82-2-3410-1780, yeonh.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2nd Progression free survival (PFS) (time frame: The time until the time of the first event(the progression of a recorded disease of breast cancer or death from all causes) in 2nd line treatment. Up to 72months). 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 3 Jan 2025.