Breast NeoplasmsPhase 3PATHWAYNCT03423199
PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
A Phase 3 study testing Palbociclib, Tamoxifen and Goserelin in people with Breast Neoplasms, run by National Cancer Center, Japan at 23 sites in 4 countries.
Trial summary
This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Palbociclib, Tamoxifen and Goserelin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 9 Feb 2018to Sep 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years of age or older with histologically or cytologically proven locally advanced or metastatic breast cancer, not amenable to resection or radiation therapy with curative intent
- Documented diagnosis of HR+/HER2- breast cancer
- Any menopausal status
- Previously untreated with any endocrine therapy for their HR+/HER2- advanced breast cancer; or progressed while on or within 3 month from prior endocrine therapy other than tamoxifen for advanced breast cancer. If patients have adjuvant endocrine therapy, they must satisfy as follows: progressed 12 months or more since prior adjuvant endocrine therapy with tamoxifen; or progressed during or after adjuvant endocrine therapy with an aromatase inhibitor.
- Measurable disease or non-measurable disease as defined by RECIST ver.1.1
- Eastern Cooperative Oncology Group (ECOG) PS 0-1
- Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
Who cannot join
- Prior treatment with any CDK inhibitor, tamoxifen, everolimus, or agent that inhibits the PI3K-mTOR pathway
- Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
- Use of strong or moderate CYP3A4 and/or CYP2D6 inhibitors or inducers
- Major surgery or any anti-cancer therapy within 2 weeks of randomization
- Prior stem cell or bone marrow transplantation
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
Japan12 sites
Hyogo Cancer Center
Akashi, Hyōgo, 6738558
Chiba Cancer Center
Chiba, 2608717
Kyusyu Cancer Center
Fukuoka, 8111395
National Cancer Center Hospital East
Kashiwa, Chiba, 2778577
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 7910280
Toranomon Hospital
Minato-Ku, Tokyo, 1058470
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
National Hospital Organization Osaka National Hospital
Osaka, 5400006
Kindai University Hospital
Ōsaka-sayama, Osaka, 5898511
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 0030804
National Cancer Center Hospital
Tokyo, 104-0045
Kanagawa Cancer Center
Yokohama, Kanagawa, 2418515
South Korea6 sites
National Cancer Center
Gyeonggi-do, 10408
Ajou University Hospital
Gyeonggi-do, 16499
Seoul National University Bundang Hospital
Gyeonggi-do, 463-707
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Severance Hospital, Yonsei University Health System
Soeul, 03722
Taiwan3 sites
National Taiwan University Hospital
Taipei, 10048
Taipei Vetarans General Hospital
Taipei, 11217
Sun Yat-Sen Cancer Center
Taipei, 11259
Singapore2 sites
National University Hospital
Singapore, 119882
National Cancer Centre Singapore
Singapore, 169610
About this study
Official title: Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib ± Goserelin in Women With Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer
This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).
- Conditions
- Breast Neoplasms
- Being tested
- Palbociclib, Placebo, Tamoxifen, Goserelin
- Keywords
- breast Cancer, palbociclib (PD-0332991), tamoxifen, goserelin, any menopausal status, hormone receptor positive, HER2 negative, locally advanced, metastatic
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called PD-0332991
Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
PlaceboDrug
Placebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
TamoxifenDrug
Tamoxifen, 20mg, orally once daily (continuously)
GoserelinDrug
For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib + Tamoxifen ± Goserelin | Experimental | Palbociclib 125 mg/day, orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously) Receives: Drug: Palbociclib; Drug: Tamoxifen; Drug: Goserelin |
| Placebo + Tamoxifen ± Goserelin | Active comparator | Placebo orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously) Receives: Drug: Placebo; Drug: Tamoxifen; Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The time from the date of randomization to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first.
Measured: Baseline up to 3.5 years
Secondary outcomes (10)
Overall Survival (OS)
The time from date of randomization to date of death due to any cause.
Measured: From the randomization of the last patient up to 3 years
Survival Probabilities at 1 year, 2 year, and 3 year
The probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate.
Measured: From the randomization of the last patient up to 3 years
Objective Response (OR)
Complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) ver.1.1 recorded from randomization until disease progression or death due to any cause.
Measured: Baseline up to 3.5 years
Duration of Response (DR)
The time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Measured: Baseline up to 3.5 years
Clinical Benefit Response (CBR)
CR or PR or SD >=24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death of any cause.
Measured: Baseline up to 3.5 years
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.
Measured: Baseline up to 3.5 years
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.
Measured: Baseline up to 3.5 years
Trough plasma concentrations of palbociclib
Ctrough for palbociclib
Measured: Cycle 1/Day 15 and Cycle 2/Day 15
Trough plasma concentrations of tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen
Ctrough for tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen
Measured: Cycle 2/Day 15 and Cycle 3/Day 15
Treatment-Emergent Adverse Events
Measured: From the first dose of the investigational product until 28 days after the last dose of study drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start9 Feb 2018
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Collaborators
- Pfizer, Korean Cancer Study Group
- Responsible party
- Sponsor
- Investigators
- Kan Yonemori, MD, PhD, Study chair, Department of Breast and Medical Oncology, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423199
- Sponsor's protocol ID
- NCCH1607
- Other IDs
- WI217662
- Acronym
- PATHWAY
- Status last verified
- Mar 2024
- First submitted
- 9 Jan 2018
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Yamanaka T, Sohn J, Sudo K, Mukai H, Yamamoto N, Chung CF, Lu YS, Lee KH, Lee SC, Iwasa T, Iwata H, Watanabe K, Jung KH, Tanabe Y, Kang SY, Yasojima H, Aogi K, Tokunaga E, Sim SH, Yap YS, Matsumoto K, Tseng LM, Umeyama Y, Noguchi E, Hata T, Kuchiba A, Shibata T, Nakamura K, Fujiwara Y, Tamura K, Yonemori K. Quality of life with palbociclib plus tamoxifen in hormone receptor-positive, HER2-negative advanced breast cancer: results from PATHWAY, an Asian international, double-blind, randomized phase 3 trial. Breast Cancer. 2026 Jun 24. doi: 10.1007/s12282-026-01865-0. Online ahead of print.
PubMed 42340618Noguchi E, Yamanaka T, Mukai H, Yamamoto N, Chung CF, Lu YS, Chang DY, Sohn J, Kim GM, Lee KH, Lee SC, Iwasa T, Iwata H, Watanabe K, Jung KH, Tanabe Y, Kang SY, Yasojima H, Aogi K, Tokunaga E, Sim SH, Yap YS, Matsumoto K, Tseng LM, Umeyama Y, Sudo K, Kojima Y, Hata T, Kuchiba A, Shibata T, Nakamura K, Fujiwara Y, Tamura K, Yonemori K. A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer. NPJ Breast Cancer. 2024 Aug 22;10(1):76. doi: 10.1038/s41523-024-00684-w.
PubMed 39174547
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib ± Goserelin in Women With Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03423199
- Acronym / sponsor ID
- PATHWAY / NCCH1607
- Conditions
- Breast Neoplasms
- Keywords
- breast Cancer, palbociclib (PD-0332991), tamoxifen, goserelin, any menopausal status, hormone receptor positive, HER2 negative, locally advanced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Cancer Center, JapanOther government
- Collaborators
- Pfizer, Korean Cancer Study Group
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Feb 2018 (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 conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palbociclib + Tamoxifen ± Goserelin | Experimental | Drug: Palbociclib, Drug: Tamoxifen, Drug: GoserelinPalbociclib 125 mg/day, orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously) |
| Placebo + Tamoxifen ± Goserelin | Active comparator | Drug: Placebo, Drug: Tamoxifen, Drug: GoserelinPlacebo orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women 18 years of age or older with histologically or cytologically proven locally advanced or metastatic breast cancer, not amenable to resection or radiation therapy with curative intent
- Documented diagnosis of HR+/HER2- breast cancer
- Any menopausal status
- Previously untreated with any endocrine therapy for their HR+/HER2- advanced breast cancer; or progressed while on or within 3 month from prior endocrine therapy other than tamoxifen for advanced breast cancer. If patients have adjuvant endocrine therapy, they must satisfy as follows: progressed 12 months or more since prior adjuvant endocrine therapy with tamoxifen; or progressed during or after adjuvant endocrine therapy with an aromatase inhibitor.
- Measurable disease or non-measurable disease as defined by RECIST ver.1.1
Key exclusion criteria (5 listed)
- Prior treatment with any CDK inhibitor, tamoxifen, everolimus, or agent that inhibits the PI3K-mTOR pathway
- Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
- Use of strong or moderate CYP3A4 and/or CYP2D6 inhibitors or inducers
- Major surgery or any anti-cancer therapy within 2 weeks of randomization
- Prior stem cell or bone marrow transplantation
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 |
|---|---|---|
| PalbociclibAlso: PD-0332991Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment | Drug | Palbociclib + Tamoxifen ± Goserelin |
| PlaceboPlacebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment | Drug | Placebo + Tamoxifen ± Goserelin |
| TamoxifenTamoxifen, 20mg, orally once daily (continuously) | Drug | Palbociclib + Tamoxifen ± Goserelin, Placebo + Tamoxifen ± Goserelin |
| GoserelinFor pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks | Drug | Palbociclib + Tamoxifen ± Goserelin, Placebo + Tamoxifen ± Goserelin |
Primary outcome
Progression-free survival (PFS)
Time frame: Baseline up to 3.5 years
The time from the date of randomization to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first.
10 secondary outcomes
Overall Survival (OS)
Time frame: From the randomization of the last patient up to 3 years
Survival Probabilities at 1 year, 2 year, and 3 year
Time frame: From the randomization of the last patient up to 3 years
Objective Response (OR)
Time frame: Baseline up to 3.5 years
Duration of Response (DR)
Time frame: Baseline up to 3.5 years
Clinical Benefit Response (CBR)
Time frame: Baseline up to 3.5 years
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
Time frame: Baseline up to 3.5 years
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
Time frame: Baseline up to 3.5 years
Trough plasma concentrations of palbociclib
Time frame: Cycle 1/Day 15 and Cycle 2/Day 15
Trough plasma concentrations of tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen
Time frame: Cycle 2/Day 15 and Cycle 3/Day 15
Treatment-Emergent Adverse Events
Time frame: From the first dose of the investigational product until 28 days after the last dose of study drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 42340618Yamanaka T, Sohn J, Sudo K, Mukai H, Yamamoto N, Chung CF, Lu YS, Lee KH, Lee SC, Iwasa T, Iwata H, Watanabe K, Jung KH, Tanabe Y, Kang SY, Yasojima H, Aogi K, Tokunaga E, Sim SH, Yap YS, Matsumoto K, Tseng LM, Umeyama Y, Noguchi E, Hata T, Kuchiba A, Shibata T, Nakamura K, Fujiwara Y, Tamura K, Yonemori K. Quality of life with palbociclib plus tamoxifen in hormone receptor-positive, HER2-negative advanced breast cancer: results from PATHWAY, an Asian international, double-blind, randomized phase 3 trial. Breast Cancer. 2026 Jun 24. doi: 10.1007/s12282-026-01865-0. Online ahead of print.
- Derived from this study: PubMed 39174547Noguchi E, Yamanaka T, Mukai H, Yamamoto N, Chung CF, Lu YS, Chang DY, Sohn J, Kim GM, Lee KH, Lee SC, Iwasa T, Iwata H, Watanabe K, Jung KH, Tanabe Y, Kang SY, Yasojima H, Aogi K, Tokunaga E, Sim SH, Yap YS, Matsumoto K, Tseng LM, Umeyama Y, Sudo K, Kojima Y, Hata T, Kuchiba A, Shibata T, Nakamura K, Fujiwara Y, Tamura K, Yonemori K. A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer. NPJ Breast Cancer. 2024 Aug 22;10(1):76. doi: 10.1038/s41523-024-00684-w.
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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.
Kan Yonemori, MD, PhD study chair
Department of Breast and Medical Oncology, National Cancer Center Hospital
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Palbociclib, Tamoxifen and Goserelin in people with Breast Neoplasms, run by National Cancer Center, Japan at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan, South Korea, Taiwan, Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Baseline up to 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423199, which also lists 2 linked publications.
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 22 Mar 2024.