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Premenopausal Endocrine Responsive Chemotherapy Trial (PERCHE)

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
chemotherapy
exemestane
tamoxifen
triptorelin
oophorectomy
ovarian irradiation
Sponsored by
ETOP IBCSG Partners Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IIIA breast cancer, stage I breast cancer, stage II breast cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed breast cancer confined to the breast and axillary nodes No distant metastatic disease Tumor detected in the internal mammary chain by sentinel node procedure allowed Must have undergone 1 of the following procedures for primary breast cancer within the past 12 weeks and have no known clinical residual locoregional disease: Total mastectomy with or without adjuvant radiotherapy Breast-conserving surgery (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins clear* of invasive cancer and ductal carcinoma in situ) followed by radiotherapy NOTE: *If all other margins are clear, a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed Prior axillary lymph node dissection or negative axillary sentinel node biopsy required Patients with microscopically positive axillary sentinel nodes allowed provided they were evaluated on a clinical trial evaluating microscopically positive lymph nodes No locally advanced, inoperable breast cancer, including any of the following characteristics: Inflammatory breast cancer Supraclavicular node involvement Enlarged internal mammary nodes (unless pathologically negative) No prior ipsilateral or contralateral invasive breast cancer Histologically diagnosed synchronous bilateral invasive breast cancer within the past 2 months allowed if the bilateral disease meets all other eligibility criteria Hormone receptor status: Estrogen receptor and/or progesterone receptor positive in each tumor At least 10% of tumor cells positive by immunohistochemistry PATIENT CHARACTERISTICS: Age Premenopausal Sex Female Menopausal status Premenopausal Estradiol in the premenopausal range after surgery Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic No systemic hepatic disease that would preclude prolonged follow-up Renal No systemic renal disease that would preclude prolonged follow-up Cardiovascular No prior deep venous thrombosis and/or embolism unless patient is medically suitable No systemic cardiovascular disease that would preclude prolonged follow-up Pulmonary No systemic pulmonary disease that would preclude prolonged follow-up Other Not pregnant or nursing Fertile patients must use effective nonhormonal contraception No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ without invasion, contralateral or ipsilateral carcinoma in situ of the breast No prior or concurrent nonbreast invasive malignancy within the past 5 years that is nonrecurrent including any of the following: Stage I papillary thyroid cancer Stage Ia carcinoma of the cervix Stage Ia or b endometrioid endometrial cancer Borderline or stage I ovarian cancer No other nonmalignant systemic disease that would preclude prolonged follow-up No history of noncompliance with medical regimens No psychiatric, addictive, or other disorder that would preclude study compliance or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior neoadjuvant or adjuvant chemotherapy Neoadjuvant or adjuvant trastuzumab (Herceptin®) allowed Endocrine therapy No prior neoadjuvant or adjuvant endocrine therapy after breast cancer diagnosis No prior tamoxifen or other selective estrogen-receptor modulator (e.g., raloxifene) within 1 year before the breast cancer diagnosis No other concurrent oral or transdermal hormonal therapy, including any of the following: Estrogen Progesterone Androgens Aromatase inhibitors Hormone replacement therapy Oral or other hormonal contraceptives, including implant and depot injections Raloxifene or other selective estrogen-receptor modulators Radiotherapy See Disease Characteristics No prior ovarian irradiation Surgery See Disease Characteristics No prior bilateral oophorectomy Other No other prior neoadjuvant therapy No other concurrent investigational agents No concurrent bisphosphonates unless bone density has been documented at least 1.5 standard deviations below the young adult normal mean or the patient is participating in a randomized clinical trial setting testing bisphosphonates in the adjuvant breast cancer setting

Sites / Locations

  • National Institute of Oncology
  • Centro di Riferimento Oncologico - Aviano
  • European Institute of Oncology
  • Kantonsspital Graubuenden
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital - St. Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

OFS plus T or E

Chemotherapy plus OFS plus T or E

Arm Description

Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.

Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.

Outcomes

Primary Outcome Measures

Disease-free Survival

Secondary Outcome Measures

Overall Survival
Systemic Disease-free Survival
Sites of First Treatment Failure

Full Information

First Posted
August 6, 2003
Last Updated
September 26, 2016
Sponsor
ETOP IBCSG Partners Foundation
Collaborators
National Cancer Institute (NCI), Breast International Group
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1. Study Identification

Unique Protocol Identification Number
NCT00066807
Brief Title
Premenopausal Endocrine Responsive Chemotherapy Trial
Acronym
PERCHE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual, patients were followed until completion of 5 yrs treatment
Study Start Date
August 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ETOP IBCSG Partners Foundation
Collaborators
National Cancer Institute (NCI), Breast International Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial [recommended option]. The trial was terminated early due to poor accrual.
Detailed Description
OBJECTIVES: Compare ovarian function suppression and tamoxifen or exemestane with vs without adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast cancer. Compare the disease-free and overall survival of patients treated with these regimens. Compare sites of first treatment failure in patients treated with these regimens. Compare the incidence of second nonbreast malignancies in patients treated with these regimens. Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens. PLANNED OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more), method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation), chemotherapy if randomized to arm II (not containing vs containing an anthracycline or taxane), and endocrine agent (tamoxifen vs exemestane vs selected by subsequent randomization in the TEXT trial). Treatment duration is five years. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. NOTE: Trial was terminated early due to poor accrual.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IIIA breast cancer, stage I breast cancer, stage II breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OFS plus T or E
Arm Type
Experimental
Arm Description
Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
Arm Title
Chemotherapy plus OFS plus T or E
Arm Type
Experimental
Arm Description
Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Other Intervention Name(s)
Ellence, Epirubicin Ebewe
Intervention Description
Planned duration of chemotherapy: 2 months if an anthracycline is included (e.g., 4 cycles of EC or AC) or 4 months if no anthracycline is given (e.g., 6 cycles of CMF) is recommended. Unless medically contraindicated, an anthracycline-containing regimen using epirubicin should be given.
Intervention Type
Drug
Intervention Name(s)
exemestane
Other Intervention Name(s)
Aromasin
Intervention Description
Exemestane 25 mg orally daily for until 5 years from date of randomization, unless relapse or intolerance should occur earlier.
Intervention Type
Drug
Intervention Name(s)
tamoxifen
Other Intervention Name(s)
Nolvadex
Intervention Description
Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless relapse or intolerance should occur earlier.
Intervention Type
Drug
Intervention Name(s)
triptorelin
Other Intervention Name(s)
GnRH analog, Trelstar Depot
Intervention Description
Triptorelin (GnRH analogue) 3.75 mg by intramuscular injection every 28 days for 5 years from randomization, unless relapse or intolerance should occur earlier or surgical oophorectomy or ovarian irradiation is subsequently performed.
Intervention Type
Procedure
Intervention Name(s)
oophorectomy
Intervention Description
Bilateral surgical oophorectomy via laparotomy or laparoscopy.
Intervention Type
Procedure
Intervention Name(s)
ovarian irradiation
Intervention Description
Bilateral ovarian irradiation.
Primary Outcome Measure Information:
Title
Disease-free Survival
Time Frame
For first time at a median follow up approximately 5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
For first time at a median follow up approximately 5 years
Title
Systemic Disease-free Survival
Time Frame
For first time at a median follow up approximately 5 years
Title
Sites of First Treatment Failure
Time Frame
For first time at a median follow up approximately 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer confined to the breast and axillary nodes No distant metastatic disease Tumor detected in the internal mammary chain by sentinel node procedure allowed Must have undergone 1 of the following procedures for primary breast cancer within the past 12 weeks and have no known clinical residual locoregional disease: Total mastectomy with or without adjuvant radiotherapy Breast-conserving surgery (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins clear* of invasive cancer and ductal carcinoma in situ) followed by radiotherapy NOTE: *If all other margins are clear, a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed Prior axillary lymph node dissection or negative axillary sentinel node biopsy required Patients with microscopically positive axillary sentinel nodes allowed provided they were evaluated on a clinical trial evaluating microscopically positive lymph nodes No locally advanced, inoperable breast cancer, including any of the following characteristics: Inflammatory breast cancer Supraclavicular node involvement Enlarged internal mammary nodes (unless pathologically negative) No prior ipsilateral or contralateral invasive breast cancer Histologically diagnosed synchronous bilateral invasive breast cancer within the past 2 months allowed if the bilateral disease meets all other eligibility criteria Hormone receptor status: Estrogen receptor and/or progesterone receptor positive in each tumor At least 10% of tumor cells positive by immunohistochemistry PATIENT CHARACTERISTICS: Age Premenopausal Sex Female Menopausal status Premenopausal Estradiol in the premenopausal range after surgery Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic No systemic hepatic disease that would preclude prolonged follow-up Renal No systemic renal disease that would preclude prolonged follow-up Cardiovascular No prior deep venous thrombosis and/or embolism unless patient is medically suitable No systemic cardiovascular disease that would preclude prolonged follow-up Pulmonary No systemic pulmonary disease that would preclude prolonged follow-up Other Not pregnant or nursing Fertile patients must use effective nonhormonal contraception No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ without invasion, contralateral or ipsilateral carcinoma in situ of the breast No prior or concurrent nonbreast invasive malignancy within the past 5 years that is nonrecurrent including any of the following: Stage I papillary thyroid cancer Stage Ia carcinoma of the cervix Stage Ia or b endometrioid endometrial cancer Borderline or stage I ovarian cancer No other nonmalignant systemic disease that would preclude prolonged follow-up No history of noncompliance with medical regimens No psychiatric, addictive, or other disorder that would preclude study compliance or giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior neoadjuvant or adjuvant chemotherapy Neoadjuvant or adjuvant trastuzumab (Herceptin®) allowed Endocrine therapy No prior neoadjuvant or adjuvant endocrine therapy after breast cancer diagnosis No prior tamoxifen or other selective estrogen-receptor modulator (e.g., raloxifene) within 1 year before the breast cancer diagnosis No other concurrent oral or transdermal hormonal therapy, including any of the following: Estrogen Progesterone Androgens Aromatase inhibitors Hormone replacement therapy Oral or other hormonal contraceptives, including implant and depot injections Raloxifene or other selective estrogen-receptor modulators Radiotherapy See Disease Characteristics No prior ovarian irradiation Surgery See Disease Characteristics No prior bilateral oophorectomy Other No other prior neoadjuvant therapy No other concurrent investigational agents No concurrent bisphosphonates unless bone density has been documented at least 1.5 standard deviations below the young adult normal mean or the patient is participating in a randomized clinical trial setting testing bisphosphonates in the adjuvant breast cancer setting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosalba Torrisi, MD
Organizational Affiliation
Breast International Group, European Institute of Oncology, Milano, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Edith A. Perez, MD
Organizational Affiliation
North American Intergroup, Mayo Clinic Jacksonville, Jacksonville, USA
Official's Role
Study Chair
Facility Information:
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Kantonsspital Graubuenden
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
Citation
Francis P, Fleming G, Nasi ML, et al.: Tailored treatment investigations for premenopausal women with endocrine responsive (ER+ and/or PGR+) breast cancer: the SOFT, TEXT, and PERCHE trials. [Abstract] The Breast 12 (Suppl 1): A-P104, S44, 2003.
Results Reference
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Premenopausal Endocrine Responsive Chemotherapy Trial

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