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Breast CancerPhase 3PERCHENCT00066807

Premenopausal Endocrine Responsive Chemotherapy Trial

A Phase 3 study testing chemotherapy, exemestane and tamoxifen in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 6 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
chemotherapy, exemestane and tamoxifen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
6 sitesin 3 countries
Study dates
Aug 2003to Dec 2006
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Switzerland3 sites

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

Italy2 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • European Institute of Oncology

    Milan, 20141

Other trials in Italy

Hungary1 site

  • National Institute of Oncology

    Budapest, 1122

Other trials in Hungary

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
chemotherapy, exemestane, tamoxifen, triptorelin, oophorectomy
Keywords
stage IIIA breast cancer, stage I breast cancer, stage II breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chemotherapyDrug

    Also called Ellence, Epirubicin Ebewe

    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.

  • exemestaneDrug

    Also called Aromasin

    Exemestane 25 mg orally daily for until 5 years from date of randomization, unless relapse or intolerance should occur earlier.

  • tamoxifenDrug

    Also called Nolvadex

    Tamoxifen 20 mg orally daily until 5 years from date of randomization, unless relapse or intolerance should occur earlier.

  • triptorelinDrug

    Also called GnRH analog, Trelstar Depot

    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.

  • oophorectomyProcedure or surgery

    Bilateral surgical oophorectomy via laparotomy or laparoscopy.

  • ovarian irradiationProcedure or surgery

    Bilateral ovarian irradiation.

Study groups in NCT00066807
Study groupRoleWhat they receive
OFS plus T or EExperimentalOvarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
Receives: Drug: exemestane; Drug: tamoxifen; Drug: triptorelin; Procedure: oophorectomy; Procedure: ovarian irradiation
Chemotherapy plus OFS plus T or EExperimentalChemotherapy 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.
Receives: Drug: chemotherapy; Drug: exemestane; Drug: tamoxifen; Drug: triptorelin; Procedure: oophorectomy; Procedure: ovarian irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free Survival

    Measured: For first time at a median follow up approximately 5 years

Secondary outcomes (3)

  1. Overall Survival

    Measured: For first time at a median follow up approximately 5 years

  2. Systemic Disease-free Survival

    Measured: For first time at a median follow up approximately 5 years

  3. Sites of First Treatment Failure

    Measured: For first time at a median follow up approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionDec 2006
  4. Study completionDec 2006

Why it stopped: Poor accrual, patients were followed until completion of 5 yrs treatment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066807
Sponsor's protocol ID
IBCSG 26-02 / BIG 4-02
Other IDs
NABCI-IBCSG-26-02, EU-20401, 2005-002626-59, CDR0000318832, 2005
Acronym
PERCHE
Status last verified
Sep 2016
First submitted
6 Aug 2003
Last updated
28 Oct 2016
Data monitoring committee
Yes

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chemotherapy, exemestane and tamoxifen in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland, Italy, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (time frame: For first time at a median follow up approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066807, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.

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