HER2-positive Breast CancerPhase 1/2NCT03881878
TAHP for Patients With HER2-positive Early Breast Cancer and Subsequent AHP Adjuvant tHerapy After Surgery
A Phase 1/2 study testing TAHP and AHP and TAHP plus AC and AHP in people with HER2-positive Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study was phase IB-II clinical trial that designed to evaluate the efficacy and safety of docetaxel + atezolizumab + Herceptin sc plus pertuzumab(TAHP) plus adjuvant therapy of atezolizumab + trastuzumab + pertuzumab(AHP) after surgery in female patients with HER2-positive early breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- TAHP and AHP and TAHP plus AC and AHP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2019to 31 Oct 2022
- Phase
- Phase 1/2
- 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
- Patient is an adult, female ≥ 18 years old at the time of informed consent
- Patient has histologically confirmed diagnosis of breast cancer
- Patients with locally advanced breast cancer (T2-3N0-3)
- Patients with early breast cancer with high-risk (T1cN1)
- Patients with locally advanced inflammatory breast cancer
- Patient has HER2-positive breast cancer as 3+ by IHC or in-situ hybridization (ISH) amplified BC patients
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- ER+ or ER-
- Agree to informed consent and willing and able to comply with the protocol
- Available pre-chemotherapy and surgery tissue (except pCR)
- For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drugs. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year. Barrier methods must always be supplemented with the use of a spermicide.
- Patient has adequate bone marrow and organ function
- LVEF ≥55% at baseline
Who cannot join
- HER2-negative in surgery sample
- Tumor size less than 2cm or and N0
- Patients who have metastatic disease (M1)
- Patients who are not available tumor tissue
- Pregnant or lactating or intending to become pregnant during or within 7 months after the last dose of study treatment
- Patients who have serious underlying co-morbidities which could cause end-organ dysfunction
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- Any previous treatment against including chemo, hormonal therapy
- Administration of a live, attenuated vaccine within 4 weeks before Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- Patients with prior allogeneic stem cell or solid organ transplantation
- History of autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- History of idiopathic pulmonary fibrosis (including bronchiolitis obliterans with organizing pneumonia) or evidence of active pneumonitis on screening chest computed tomography scan
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
- History of HIV infection, active hepatitis B (chronic or acute), or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen [anti-HBc] test) are eligible.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction assay (PCR) is negative for HCV RNA
- Active tuberculosis
- Severe infections within 4 weeks prior to Day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Signs or symptoms of significant infection within 2 weeks prior to Day 1
- Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervix cancer are generally eligible
- Congestive heart failure or abnormal LVEF(LVEF is not ≥55% at baseline)
- Total bili >1.5 ULN (except for Gilbert's syndrome), AST/ALT > 1.5 ULN, ALP > 2.5 ULN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Docetaxel Plus Atezolizumab Plus Herceptin SC and Pertuzumab (TAHP) for Patients With HER2-positive Early Breast Cancer and Subsequent Atezolizumab Plus Herceptin SC and Pertuzumab (AHP) Adjuvant tHerapy After Surgery
This study was phase IB-II clinical trial that designed to evaluate the efficacy and safety of docetaxel + atezolizumab + Herceptin sc plus pertuzumab(TAHP) plus adjuvant therapy of atezolizumab + trastuzumab + pertuzumab(AHP) after surgery in female patients with HER2-positive early breast cancer.
Adjuvant AHP (atezolizumab + Herceptin SC + pertuzumab) will be continued for remaining 1 year.
For non-p CR patients, they are going to treat with 4 cycles of AC rather than Taxane only before AHP adjuvant therapy.
Read the detailed description
A, Neoadjuvant setting); 6 cycles q3weeks, intravenous(IV) administration
- Docetaxel (75mg/m2, intravenous(IV)) Day(D)1
- Atezolizumab (1200mg, IV) D1
- Herceptin sc (600mg subcutaneous(SC))D1
- Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg(IV))D1
B, Adjuvant setting : 11-12 cycles q3weeks [patients with pCR]
- Atezolizumab (1200mg, IV)
- Trastuzumab (600mg, SC)
- Pertuzumab (420mg, IV) D1
[patients with non-pCR]
- Doxorubicin(60mg/m2), cyclophosphamide (600mg/m2) D1 X 4cycles 3weeks
- Atezolizumab (1200mg, IV)
- Trastuzumab (600mg, SC)
- Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks
- Conditions
- HER2-positive Breast Cancer
- Being tested
- TAHP and AHP, TAHP plus AC and AHP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAHP and AHPDrug
(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
- Docetaxel (75mg/m2, IV)
- Atezolizumab (1200mg, IV)
- Tastuzumab (600mg, SC)
- Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : patients with pCR:D1 X 11-12 cycles, q3weeks
- Atezolizumab (1200mg, IV)
- Trastuzumab (600mg, SC)
- Pertuzumab (420mg, IV)
TAHP plus AC and AHPDrug
(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
- Docetaxel (75mg/m2, IV)
- Atezolizumab (1200mg, IV)
- Tastuzumab (600mg, SC)
- Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : patients with non-pCR
- Doxorubicin(60mg/m2) plus cyclophosphamide (600mg/m2) D1 X 4cycles q3weeks followed by
- Atezolizumab (1200mg, IV), Trastuzumab (600mg, SC) and Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks
| Study group | Role | What they receive |
|---|---|---|
| pathologic Complete response | Experimental | (A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
* Docetaxel (75mg/m2, IV)
* Atezolizumab (1200mg, IV)
* Trastuzumab (600mg, SC)
* Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV)
(B, Adjuvant setting) : D1 X 11-12 cycles, q3weeks
* Atezolizumab (1200mg, IV)
* Trastuzumab (600mg, SC)
* Pertuzumab (420mg, IV) Receives: Drug: TAHP and AHP |
| non-pathologic Complete response | Experimental | (A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
* Docetaxel (75mg/m2, IV)
* Atezolizumab (1200mg, IV)
* Trastuzumab (600mg, SC)
* Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV)
(B, Adjuvant setting) :
* Doxorubicin(60mg/m2) plus cyclophosphamide (600mg/m2) : D1 X 4cycles q3weeks followed by
* Atezolizumab (1200mg, IV), Trastuzumab (600mg, SC) and Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks Receives: Drug: TAHP plus AC and AHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic CR(pCR) rate of neo-adjuvant chemotherapy
pCR rate of neoadjuvant chemotherapy with the patients with HER2+ EBC
Measured: Pathologic Clinical response is perforemed after end of cycle 6 (each cycle is 21days).
Secondary outcomes (1)
Event free survival(EFS)
Event free survival of the patient with pCR vs. non-pCR
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start27 May 2019 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2-positive 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- (A, Neoadjuvant setting): TAHP (Docetaxel, Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 6 cycles q3weeks, intravenous(IV) administration (B, Adjuvant setting) : patients with pCR: AHP(Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 11-12 cycles q3weeks patients with non-pCR: Doxorubicin plus cyclophosphamide: D1 X 4cycles q3weeks followed by AHP (Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 11-12 cycles q3weeks
- Masking
- None (open label)
- Enrolment
- 67 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
- NCT03881878
- Sponsor's protocol ID
- 2019-01-064
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahn HK, Sim SH, Suh KJ, Kim MH, Jeong JH, Kim JY, Lee DW, Ahn JH, Chae H, Lee KH, Kim JH, Lee KS, Sohn JH, Choi YL, Im SA, Jung KH, Park YH. Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer: The Neo-PATH Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Sep 1;8(9):1271-1277. doi: 10.1001/jamaoncol.2022.2310.
PubMed 35797012
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel Plus Atezolizumab Plus Herceptin SC and Pertuzumab (TAHP) for Patients With HER2-positive Early Breast Cancer and Subsequent Atezolizumab Plus Herceptin SC and Pertuzumab (AHP) Adjuvant tHerapy After Surgery
- ClinicalTrials.gov ID
- NCT03881878
- Acronym / sponsor ID
- 2019-01-064
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 27 May 2019 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 20 Mar 2019 (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 was phase IB-II clinical trial that designed to evaluate the efficacy and safety of docetaxel + atezolizumab + Herceptin sc plus pertuzumab(TAHP) plus adjuvant therapy of atezolizumab + trastuzumab + pertuzumab(AHP) after surgery in female patients with HER2-positive early breast cancer.
Adjuvant AHP (atezolizumab + Herceptin SC + pertuzumab) will be continued for remaining 1 year.
For non-p CR patients, they are going to treat with 4 cycles of AC rather than Taxane only before AHP adjuvant therapy.
Detailed description
A, Neoadjuvant setting); 6 cycles q3weeks, intravenous(IV) administration
- Docetaxel (75mg/m2, intravenous(IV)) Day(D)1
- Atezolizumab (1200mg, IV) D1
- Herceptin sc (600mg subcutaneous(SC))D1
- Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg(IV))D1
B, Adjuvant setting : 11-12 cycles q3weeks [patients with pCR]
- Atezolizumab (1200mg, IV)
- Trastuzumab (600mg, SC)
- Pertuzumab (420mg, IV) D1
[patients with non-pCR]
- Doxorubicin(60mg/m2), cyclophosphamide (600mg/m2) D1 X 4cycles 3weeks
- Atezolizumab (1200mg, IV)
- Trastuzumab (600mg, SC)
- Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- (A, Neoadjuvant setting): TAHP (Docetaxel, Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 6 cycles q3weeks, intravenous(IV) administration (B, Adjuvant setting) : patients with pCR: AHP(Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 11-12 cycles q3weeks patients with non-pCR: Doxorubicin plus cyclophosphamide: D1 X 4cycles q3weeks followed by AHP (Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 11-12 cycles q3weeks
| Arm | Type | Receives |
|---|---|---|
| pathologic Complete response | Experimental | Drug: TAHP and AHP(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks * Docetaxel (75mg/m2, IV) * Atezolizumab (1200mg, IV) * Trastuzumab (600mg, SC) * Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : D1 X 11-12 cycles, q3weeks * Atezolizumab (1200mg, IV) * Trastuzumab (600mg, SC) * Pertuzumab (420mg, IV) |
| non-pathologic Complete response | Experimental | Drug: TAHP plus AC and AHP(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks * Docetaxel (75mg/m2, IV) * Atezolizumab (1200mg, IV) * Trastuzumab (600mg, SC) * Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : * Doxorubicin(60mg/m2) plus cyclophosphamide (600mg/m2) : D1 X 4cycles q3weeks followed by * Atezolizumab (1200mg, IV), Trastuzumab (600mg, SC) and Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient is an adult, female ≥ 18 years old at the time of informed consent
- Patient has histologically confirmed diagnosis of breast cancer
- Patients with locally advanced breast cancer (T2-3N0-3)
- Patients with early breast cancer with high-risk (T1cN1)
- Patients with locally advanced inflammatory breast cancer
Key exclusion criteria (22 listed)
- HER2-negative in surgery sample
- Tumor size less than 2cm or and N0
- Patients who have metastatic disease (M1)
- Patients who are not available tumor tissue
- Pregnant or lactating or intending to become pregnant during or within 7 months after the last dose of study treatment
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 |
|---|---|---|
| TAHP and AHP(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks * Docetaxel (75mg/m2, IV) * Atezolizumab (1200mg, IV) * Tastuzumab (600mg, SC) * Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : patients with pCR:D1 X 11-12 cycles, q3weeks * Atezolizumab (1200mg, IV) * Trastuzumab (600mg, SC) * Pertuzumab (420mg, IV) | Drug | pathologic Complete response |
| TAHP plus AC and AHP(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks * Docetaxel (75mg/m2, IV) * Atezolizumab (1200mg, IV) * Tastuzumab (600mg, SC) * Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : patients with non-pCR * Doxorubicin(60mg/m2) plus cyclophosphamide (600mg/m2) D1 X 4cycles q3weeks followed by * Atezolizumab (1200mg, IV), Trastuzumab (600mg, SC) and Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks | Drug | non-pathologic Complete response |
Primary outcome
Pathologic CR(pCR) rate of neo-adjuvant chemotherapy
Time frame: Pathologic Clinical response is perforemed after end of cycle 6 (each cycle is 21days).
pCR rate of neoadjuvant chemotherapy with the patients with HER2+ EBC
1 secondary outcome
Event free survival(EFS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 35797012Ahn HK, Sim SH, Suh KJ, Kim MH, Jeong JH, Kim JY, Lee DW, Ahn JH, Chae H, Lee KH, Kim JH, Lee KS, Sohn JH, Choi YL, Im SA, Jung KH, Park YH. Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer: The Neo-PATH Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Sep 1;8(9):1271-1277. doi: 10.1001/jamaoncol.2022.2310.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAHP and AHP and TAHP plus AC and AHP in people with HER2-positive 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 13 inclusion and 22 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 21 Mar 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeon-hee Park, MD,PhD (2-3410-3459 ext. 82, yeonh.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic CR(pCR) rate of neo-adjuvant chemotherapy (time frame: Pathologic Clinical response is perforemed after end of cycle 6 (each cycle is 21days).). 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 NCT03881878, which also lists 1 linked publication.
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 21 Mar 2019.