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TAHP for Patients With HER2-positive Early Breast Cancer and Subsequent AHP Adjuvant tHerapy After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881878
Recruitment Status : Not yet recruiting
First Posted : March 20, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Yeon Hee Park, Samsung Medical Center

Brief 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.

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.


Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Drug: TAHP and AHP Drug: TAHP plus AC and AHP Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 27, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: pathologic Complete response

(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)
Drug: 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)

Experimental: non-pathologic Complete response

(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
Drug: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Event free survival(EFS) [ Time Frame: 3 years ]
    Event free survival of the patient with pCR vs. non-pCR


Other Outcome Measures:
  1. Adverse events will be measured by the CTCAE scale, version 5.0 [ Time Frame: 1 year ]
    safety and toxicity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is an adult, female ≥ 18 years old at the time of informed consent
  2. Patient has histologically confirmed diagnosis of breast cancer
  3. Patients with locally advanced breast cancer (T2-3N0-3)
  4. Patients with early breast cancer with high-risk (T1cN1)
  5. Patients with locally advanced inflammatory breast cancer
  6. Patient has HER2-positive breast cancer as 3+ by IHC or in-situ hybridization (ISH) amplified BC patients
  7. ER+ or ER-
  8. Agree to informed consent and willing and able to comply with the protocol
  9. Available pre-chemotherapy and surgery tissue (except pCR)
  10. 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.

  11. Patient has adequate bone marrow and organ function
  12. LVEF ≥55% at baseline

Exclusion Criteria:

  1. HER2-negative in surgery sample
  2. Tumor size less than 2cm or and N0
  3. Patients who have metastatic disease (M1)
  4. Patients who are not available tumor tissue
  5. Pregnant or lactating or intending to become pregnant during or within 7 months after the last dose of study treatment
  6. Patients who have serious underlying co-morbidities which could cause end-organ dysfunction
  7. Any previous treatment against including chemo, hormonal therapy
  8. 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
  9. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  10. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  11. Patients with prior allogeneic stem cell or solid organ transplantation
  12. 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
  13. History of idiopathic pulmonary fibrosis (including bronchiolitis obliterans with organizing pneumonia) or evidence of active pneumonitis on screening chest computed tomography scan
  14. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
  15. 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.
  16. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction assay (PCR) is negative for HCV RNA
  17. Active tuberculosis
  18. 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
  19. Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
  20. 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
  21. Congestive heart failure or abnormal LVEF(LVEF is not ≥55% at baseline)
  22. Total bili >1.5 ULN (except for Gilbert's syndrome), AST/ALT > 1.5 ULN, ALP > 2.5 ULN

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881878


Contacts
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Contact: Yeon-hee Park, MD,PhD 2-3410-3459 ext 82 yeonh.park@samsung.com
Contact: hyunjung shin, CRC 2-3410-6763 ext 82 hjds.shin@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Yeon Hee Park, Clinical Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03881878    
Other Study ID Numbers: 2019-01-064
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases