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NCT03644186

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

Datenbasis: WHO (Import vom 18.10.2020)
Geändert: 18.10.2020
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Breast Cancer;Estrogen Receptor Positive Tumor;HER2-positive Breast Cancer

Interventions (Datenquelle: WHO)

Drug: Paclitaxel;Drug: Trastuzumab;Drug: Pertuzumab;Drug: Palbociclib;Drug: Letrozole

Inclusion/Exclusion Criteria (Datenquelle: WHO)


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.

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT03644186

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03644186

Weitere Informationen zur Studie

Registrationsdatum der Studie

14.08.2018

Einschluss der ersten teilnehmenden Person

16.04.2019

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

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

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

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

Phase (Datenquelle: WHO)

Phase 2

Primäre Endpunkte (Datenquelle: WHO)

Pathological complete response (pCR)

Sekundäre Endpunkte (Datenquelle: WHO)

Pathological complete response (pCR) in the breast;Objective response;Frequency of reported adverse events;Rate of breast conserving surgery (BCS)

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Belgium, France, Italy, Switzerland

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Laura Biganzoli, MD;Etienne Brain, MD;Meredith Kissel
USL4 Hospital of Prato, Italy;Institut Curie, Paris, France
+17168340900
ibcsg55_TOUCH@fstrf.org

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Laura Biganzoli, MD;Etienne Brain, MD;Meredith Kissel
USL4 Hospital of Prato, Italy;Institut Curie, Paris, France
+17168340900
ibcsg55_TOUCH@fstrf.org

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

International Breast Cancer Study Group

Weitere Sponsoren (Datenquelle: WHO)

Pfizer;Hoffmann-La Roche

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

2017-005067-40
IBCSG 55-17