A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy - Premenopausal Endocrine Responsive Chemotherapy Trial (PERCHE)

• Register: EUCTR
• Last refreshed on: 31 July 2012
• Main ID: EUCTR2005-002626-59-DE
• Date of registration: 22/02/2007
• Prospective Registration: No
• Primary sponsor: GBG Forschung GmbH
• Public title: A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy - Premenopausal Endocrine Responsive Chemotherapy Trial (PERCHE)
• Scientific title: A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy - Premenopausal Endocrine Responsive Chemotherapy Trial (PERCHE)
• Date of first enrolment: 15/03/2006
• Target sample size: 1750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002626-59
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Germany, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Premenopausal women (estradiol (E2) in the premenopausal range (per institution parameters) following surgery). Patients should be randomized within 12 weeks after definitive surgery.

Histologically proven, resected breast cancer. Pathology material should be available for submission for central review as part of the quality control measures for this protocol.

Patients must have hormone receptor positive tumors. Hormone receptors must be determined using immunohistochemistry. ER and/or PgR must be greater than or equal to 10% of the tumor cells positive by immunohistochemical evaluation. Biochemical determination alone is not acceptable

The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure.

Patients must have had proper surgery for primary breast cancer with no known clinical residual loco-regional disease.
• A total mastectomy. Radiotherapy is optional after mastectomy.
OR
• A breast-conserving procedure (lumpectomy, quadrantectomy or partial mastectomy with margins clear of invasive cancer and DCIS). The local pathologist must document negative margins of resection in the pathology report. Radiation therapy to the conserved breast is required.

Either axillary lymph node dissection (pathological examination of at least 6 nodes recommended) or a negative axillary sentinel node biopsy [pN0(sn)] is required. Patients with positive axillary nodes require axillary dissection, except for patients with microscopically positive (pN1mi: micrometastasis > 0.2mm, none > 2.0mm) axillary sentinel nodes who are randomized in a clinical trial evaluating microscopically positive lymph nodes.

For IBCSG centers, patients must have completed baseline Quality of Life (QL) Forms prior to randomization. The only exceptions are cognitive or physical impairment that interferes with QL assessment or inability to read any of the languages available on IBCSG QL forms. For non-IBCSG centers, extent of participation in the QL study is to be determined at the activation of the trial for each cooperative group.

Written informed consent must be signed and dated by the patient and the investigator prior to randomization.

Patients must be accessible for follow-up.

Patients must be informed of and agree to data and tissue material transfer and handling, in accordance with national data protection guidelines
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients who are postmenopausal (i.e, do not have an estradiol (E2) level in the premenopausal range) after surgery.

Patients with distant metastatic disease.

Patients with locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative) are not eligible. Patients with involved internal mammary nodes detected by sentinel node biopsy that are not enlarged are eligible.

Patients with bilateral invasive breast cancer.

Patients with positive final margins (referring to only DCIS and invasive cancer, not LCIS).

Patients with clinically detectable residual axillary disease.

Patients with a history of prior ipsilateral or contralateral invasive breast cancer.

Patients with previous or concomitant malignancy EXCEPT adequately treated:
- basal or squamous cell carcinoma of the skin
- in situ carcinoma of the cervix or bladder
- contra- or ipsilateral in situ breast carcinoma.

Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent prolonged follow-up. Patients with previous deep venous thrombosis (e.g., DVT) and/or embolism can be included only if medically suitable.

Patients who have had a bilateral oophorectomy or ovarian irradiation.

Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable.

Patients who are pregnant or lactating at the time of randomization or who desire a pregnancy within 5 years. Patients planning to use additional hormonal therapy apart from the randomized treatment during the next five years including all types of hormonal contraception.

Patients who received any neoadjuvant or adjuvant endocrine therapy after their breast cancer diagnosis.

Patients who were taking tamoxifen or other SERM (e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis. Prior oral contraceptives are allowed.

Patients who received any neoadjuvant or adjuvant chemotherapy.

Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Premenopausal women with histologically proven, resected breast cancer with ER and/or PgR positive tumors for whom there is an uncertain role for adding chemotherapy to the adjuvant treatment program
MedDRA version: 7.0 Level: LLT Classification code 10057654

Intervention(s)

Product Name: Tamoxifen
Product Code: not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Tamoxifen citrate
CAS Number: 0054965241
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Product Name: Aromasin
Product Code: not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Exemestane
CAS Number: 107868-30-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Name: Decapeptyl L.P. 3.75 mg
Product Code: not applicable
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Triptorelin acetate
CAS Number: 0057773634
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.75-

Primary Outcome(s)

Secondary Objective:

Main Objective: To compare ovarian function suppression plus tamoxifen or exemestane vs. chemotherapy plus ovarian function suppression plus tamoxifen or exemestane

Primary end point(s): Disease-free survival

Secondary ID(s)

2005-002626-59-SE

26-02