Trial · Interventional

TerminatedPhase 3Results postedRegistry data

Premenopausal Endocrine Responsive Chemotherapy Trial

Short name PERCHE

NCTNCT00066807Other idIBCSG 26-02 / BIG 4-02Other idNABCI-IBCSG-26-02Other idEU-20401Other id2005-002626-59

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Poor accrual, patients were followed until completion of 5 yrs treatment

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 29 participants (actual)
Sponsor: ETOP IBCSG Partners Foundation · Network
Design: Randomized · Open label (no masking)
Countries: 3 countries
Hungary, Italy, Switzerland
Start: Aug 2003
Primary completion: Dec 2006
Completion: Dec 2006
First posted: 7 Aug 2003 (estimated)
Last update posted: 28 Oct 2016 (estimated)
Conditions: Breast Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20032004200520062007

Ph 3
PERCHE
NCT00066807
Aug 2003 to Dec 2006
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

chemotherapyDrug
exemestaneDrug
tamoxifenDrug
triptorelinDrug
oophorectomyProcedure
ovarian irradiationProcedure

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Disease-free Survival
Time frame · For first time at a median follow up approximately 5 years

Secondary outcomes(3)

Overall Survival
Time frame · For first time at a median follow up approximately 5 years
Systemic Disease-free Survival
Time frame · For first time at a median follow up approximately 5 years
Sites of First Treatment Failure
Time frame · For first time at a median follow up approximately 5 years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· For first time at a median follow up approximately 5 years

Disease-free Survival

Group	Value
OFS Plus T or E for 5 Years	not posted
Chemotherapy Plus OFS Plus T or E for 5 Years	not posted

Secondary and other outcome results(3)

Secondary outcome· For first time at a median follow up approximately 5 years

Overall Survival

Group	Value
OFS Plus T or E for 5 Years	not posted
Chemotherapy Plus OFS Plus T or E for 5 Years	not posted

Secondary outcome· For first time at a median follow up approximately 5 years

Systemic Disease-free Survival

Group	Value
OFS Plus T or E for 5 Years	not posted
Chemotherapy Plus OFS Plus T or E for 5 Years	not posted

Secondary outcome· For first time at a median follow up approximately 5 years

Sites of First Treatment Failure

Group	Value
OFS Plus T or E for 5 Years	not posted
Chemotherapy Plus OFS Plus T or E for 5 Years	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
OFS Plus T or E for 5 YearsOvarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.	–	0 / 14	0 / 14
Chemotherapy Plus OFS Plus T or E for 5 YearsChemotherapy 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.	–	6 / 15	0 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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