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To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) (TOUCH)

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: NCT03644186
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : November 30, 2020
Sponsor:
Collaborators:
Pfizer
Hoffmann-La Roche
Information provided by (Responsible Party):
International Breast Cancer Study Group

Brief Summary:
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

Condition or disease Intervention/treatment Phase
Breast Cancer Estrogen Receptor Positive Tumor HER2-positive Breast Cancer Drug: Paclitaxel Drug: Trastuzumab Drug: Pertuzumab Drug: Palbociclib Drug: Letrozole Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Open-label, Multicentre, Randomized Trial of Neoadjuvant Palbociclib in Combination With Hormonal Therapy and HER2 Blockade Versus Paclitaxel in Combination With HER2 Blockade for Postmenopausal Patients With Hormone Receptor Positive/HER2 Positive Early Breast Cancer
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Paclitaxel plus trastuzumab and pertuzumab
Receiving paclitaxel 80mg/m2 i.v. on day 1, 8, 15 every 28 days for 4 cycles, trastuzumab 600mg s.c. every 3 weeks for a total of 5 doses and pertuzumab 840 mg i.v. loading dose followed by 420 mg i.v. every 3 weeks for a total of 5 doses.
Drug: Paclitaxel
Chemotherapy plus HER2 Blockade
Other Name: Paclitaxel Sandoz

Drug: Trastuzumab
Chemotherapy plus HER2 Blockade
Other Name: Herceptin

Drug: Pertuzumab
Chemotherapy plus HER2 Blockade
Other Name: Perjeta

Experimental: Palbociclib plus letrozole plus trastuzumab and pertuzumab
Receiving palbociclib 125 mg/day orally for 21 days followed by 7 day's rest, for four 28 day cycles, letrozole 2.5 mg/day orally for 16 weeks and trastuzumab 600 mg s.c. every 3 weeks for a total of 5 doses and pertuzumab 840 mg i.v. loading dose followed by 420 mg i.v. every 3 weeks for 5 doses.
Drug: Palbociclib
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Name: Ibrance

Drug: Letrozole
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Name: Femara

Drug: Trastuzumab
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Name: Herceptin

Drug: Pertuzumab
CDK Inhibition plus Hormonal Therapy plus HER2 Blockade
Other Name: Perjeta




Primary Outcome Measures :
  1. Pathological complete response (pCR) [ Time Frame: Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped. ]
    Defined as absence of invasive tumour cells in the breast and in the axillary lymph nodes at the time of surgery (ypT0/ypTis ypN0) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual. The presence of in situ cancer after trial treatment in the absence of residual invasive disease constitutes a pCR.


Secondary Outcome Measures :
  1. Pathological complete response (pCR) in the breast [ Time Frame: Assessed at the time of breast surgery within 30 days of completion of a treatment period of up to 16 weeks. All patients who are discontinued from treatment for any reason will be documented within 30 days after surgery. ]
    Defined as the absence of invasive tumour cells in the breast at the time of surgery (ypT0/ypTis) determined from the local histopathologic evaluation according to the American Joint Committee on Cancer Staging Manual..

  2. Objective response [ Time Frame: Tumour assessments will be performed by ultrasound and mammography at screening (prior to start of treatment), and before surgery. Tumour measurements by caliper will be assessed at the same time points and at the end of cycle 2 (each cycle is 28 days). ]
    Defined as the number of patients with partial or complete response measured physically by caliper and by ultrasound and mammography. Response will be assessed using World Health Organisation tumour measurement and response criteria.

  3. Frequency of reported adverse events [ Time Frame: From the time informed consent is signed, during treatment and until 30 days after surgery. If there is no surgery, adverse events will be collected until 30 days after treatment stops. ]
    Defined by frequency of all grades for targeted adverse events, all grade 3 for non-targeted events and grade ≥2 for non-targeted events requiring medical attention according to CTCAE version 5. For each adverse event, the frequency of patients by worst grade of the adverse event will be summarized and tabulated by treatment.

  4. Rate of breast conserving surgery (BCS) [ Time Frame: Assessed at 35 months after randomization of the first patient. ]
    Defined as the number of patients undergoing BCS, divided by the number of patients in the assessable population (subset of the randomized population with RBsig status successfully determined who received at least 1 dose of medication).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Histologically confirmed invasive breast cancer, with the following characteristics:

    • Early breast cancer with tumor size >1 cm (as measured by at least one of the required examination methods of clinical examination, mammography and ultrasonography);
    • No clinical evidence of regional lymph node metastasis (via physical and/or radiological exam) (cN0) OR
    • Clinical evidence of cN1 status, defined by nodal involvement limited to clinically or radiologically detectable metastasis to movable ipsilateral level I, II axillary lymph node(s)
    • No evidence of metastasis (M0).
  2. Postmenopausal, defined by women with:

    • Prior bilateral surgical oophorectomy; OR
    • Amenorrhea and age ≥60 years; OR
    • Age <60 years and amenorrhea for 12 or more consecutive months in the absence of alternative pathological or physiological cause (including chemotherapy, tamoxifen, toremifene, ovarian suppression, or hormonally-based contraception) plus FSH and serum estradiol levels within the laboratory's reference ranges for postmenopausal women
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  4. Primary tumor must have positive estrogen receptor (ER) ≥10%
  5. Primary tumor must be HER2-positive (by IHC and/or ISH)
  6. Baseline LVEF ≥55% measured by Echocardiography (preferred) or MUGA scan
  7. Normal hematologic status:

    • Absolute neutrophil count ≥1500/mm3 (1.5 × 109/L);
    • Platelets ≥100 × 109/L;
    • Hemoglobin ≥9 g/dL (≥90 g/L).
  8. Normal renal function: serum creatinine ≤1.5 ULN
  9. Normal liver function:

    • Serum total bilirubin ≤1.5 × upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (<2 × ULN) is allowed;
    • AST or ALT ≤2.5 × ULN;
    • Alkaline phosphatase ≤2.5 × ULN.
  10. Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
  11. The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
  12. The patient agrees in writing to make tumor (mandatory diagnostic core biopsy and surgical specimen) available for submission for central pathology review and to conduct translational studies as part of this protocol.

Exclusion Criteria:

  1. Tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules) (T4 according to AJCC 8th edition cancer staging TNM)
  2. Inflammatory breast cancer
  3. Bilateral invasive breast cancer
  4. Received any prior treatment for primary invasive breast cancer
  5. Any active tumor of non-breast-cancer histology
  6. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina pectoris, ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (NYHA functional classification ≥II), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
  7. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety
  8. Contraindications or known hypersensitivity to any of the trial medications or excipients
  9. Treatment with any investigational agents within 30 days prior to expected start of trial treatment
  10. Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post major bowel resection
  11. Evidence via physical and/or radiological exam of cN2 or cN3 nodal involvement defined by: metastasis to ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted, OR involvement of ipsilateral infraclavicular, internal mammary and/or supraclavicular lymph node(s)
  12. History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. A history of prior radiation pneumonitis is not considered an exclusion criterion.

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): NCT03644186


Contacts
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Contact: Meredith Kissel +17168340900 ibcsg55_TOUCH@fstrf.org

Locations
Show Show 54 study locations
Sponsors and Collaborators
International Breast Cancer Study Group
Pfizer
Hoffmann-La Roche
Investigators
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Study Chair: Laura Biganzoli, MD USL4 Hospital of Prato, Italy
Study Chair: Etienne Brain, MD Institut Curie, Paris, France
Publications:

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Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT03644186    
Other Study ID Numbers: IBCSG 55-17
2017-005067-40 ( EudraCT Number )
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Breast Cancer Study Group:
hormone receptor positive early breast cancer
HER2 receptor positive early breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Letrozole
Palbociclib
Pertuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors