TOUCH: A study to reduce the use of chemotherapy in postmenopausal patients with ER-positive and HER2-positive breast cancer

Belgium, France, Italy, Switzerland (ICTRP)

ID di studio ICTRP
NCT03644186 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
TOUCH: Phase II open-label, multicenter, 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 (BASEC)

Titolo accademico
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 (ICTRP)

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

Malattie studiate
Breast Cancer;Estrogen Receptor Positive Tumor;HER2-positive Breast Cancer (ICTRP)

Intervento studiato
Drug: Paclitaxel;Drug: Trastuzumab;Drug: Pertuzumab;Drug: Palbociclib;Drug: Letrozole;Drug: Trastuzumab;Drug: Pertuzumab (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: Female
Maximum age: N/A
Minimum age: 18 Years
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. (ICTRP)

non disponibile

Endpoint primari e secondari
Pathological Complete Response (pCR) (ICTRP)

Pathological Complete Response (pCR) in the Breast;Objective Response;Rate of Breast Conserving Surgery (BCS) (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Pfizer;Hoffmann-La Roche (ICTRP)

Contatti aggiuntivi
Laura Biganzoli, MD;Etienne Brain, MD, USL4 Hospital of Prato, Italy,Institut Curie, Paris, France (ICTRP)

ID secondari
2017-005067-40, IBCSG 55-17 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03644186 (ICTRP)