KCCOP Protocol Summary

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The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full protocol.
Members may follow the "Full Protocol" link or contact KCCOP for complete protocol information.

 

Full Protocol

(members only)

 

Consent Form

 

HIPAA

CTSU IBCSG 25-02 - "A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer"

 

NOTE:  Pts can be enrolled concurrently on CTSU N063D (ALTTO).

 

Treatment Plan    (Supplied Drug:  Triptorelin, Exemestane)

 

Arm A

(+/- Chemo)*

Triptorelin x  5 yrs + Tamoxifen** x  5 yrs

 

Arm B

(+/- Chemo)*

Triptorelin x  5 yrs + Exemestane** x  5 yrs

 

*   If used, should begin at same time as Triptorelin.  Use of chemo determined by investigator/pt choice.

** Start after adjuv chemo has been completed or 6 wks after initiation of Triptorelin, whichever is later.

 

Treatment Schedules

RT:  RT to conserved breast is required.  RT to chest wall following mastectomy is optional (may also include nodal fields).  May be given either after all chemo or integrated into chemo.  May be concurrent w/trial hormonal therapy.

Chemo:  Planned duration of > 2 mos if anthracycline is included (e.g., 4 cycles of EC or AC) or > 4 mos if no anthracycline is given (e.g., 6 cycles of CMF) is recommended.  If anthracycline is used, an epirubicin-containing regimen is recommended.

 

Adjuv Endocrine Therapy

Triptorelin:  3.75mg, IM, q 28 days, x 5 yrs (unless relapse, intolerance, surgical oophorectomy, or ovarian RT subsequently performed)

Tamoxifen:  20mg, PO, QD, x 5 yrs (unless relapse or intolerance)

Exemestane:  25mg, PO, QD, x 5 yrs (unless relapse or intolerance)

 

Translational Investigations

Pts randomized prior to 1/1/08:  Whole blood for DNA isolation is required at pt's next visit, after appropriate informed consent

Pts randomized after 1/1/08:  Whole blood for DNA isolation required at baseline (prior to start of tx, but <14 days pre-randomiz)

 

Eligibility