Clinical trial · Interventional
Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
Randomized Phase III Trial of Herceptin® Followed by Chemotherapy Plus Herceptin® Versus the Combination of Herceptin® and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing Advanced/Metastatic Breast Cancer.
NCT00004935CI-TRIAL-00065763terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial is Life long follow-up: to reduce ressources and costs - trial terminated prematurely.
Summary
Brief summary (as posted)
RATIONALE: To compare efficacy, toxicity and quality of life of the sequential administration of Her alone followed, at PD, by the combination with Chemotherapy (Arm A) vs. the upfront combination of Her and Chemotherapy (Arm B) in patients with advanced/metastatic breast cancer. PURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin™ (Her) | Drug | — | UNRESOLVED |
| Herceptin™ (Her) + chemo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Herceptin™ (Her)
- description
- Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks; at time of progression add chemotherapy
- interventionNames
- Drug: Herceptin™ (Her)
- type
- ACTIVE_COMPARATOR
- label
- Herceptin™+Chemo
- description
- Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks, and chemotherapy
- interventionNames
- Drug: Herceptin™ (Her) + chemo
Primary outcomes (1)
- measure
- Time to progression on combined HerChemo (TTPHerChemo)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed HER2-overexpressing metastatic breast carcinoma * Clinically or radiologically measurable or evaluable disease * Bidimensionally or unidimensionally measurable lesions * No ascitic, pleural, or pericardial effusions, osteoblastic bone metastases, or carcinomatous lymphangitis of the lung as only indicator lesion * No known clinical brain or meningeal involvement * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 to 70 Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-1 OR * SAKK 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * Hemoglobin at least 10 g/dL * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 2,000/mm\^3 Hepatic: * Bilirubin normal * SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN) (3 times ULN if proven liver metastases) OR * No SGOT and/or SGPT greater than 1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN Renal: * Creatinine no greater than 1.25 times ULN Cardiovascular: * LVEF normal * No history of atrial ventricular arrhythmia, congestive heart failure, or angina pectoris, even if medically controlled * No history of second or third-degree heart blocks * No uncontrolled hypertension Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No pre-existing motor or sensory neuropathy grade 2 or greater * No psychiatric disorder that would preclude informed consent * No other prior malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No definite contraindications for use of corticosteroids * No other concurrent serious illness or medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior adjuvant or neoadjuvant chemotherapy allowed * No more than 2 prior chemotherapy regimens for metastatic disease * No prior cumulative dose of doxorubicin greater than 240 mg/m\^2 * No prior cumulative dose of epirubicin greater than 360 mg/m\^2 * No prior taxanes Endocrine therapy: * Prior hormonal therapy as adjuvant treatment or for metastatic disease allowed * No concurrent corticosteroids unless started more than 6 months prior to study and at low doses (i.e., no greater than 20 mg methylprednisolone or equivalent) Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent anticancer drugs * No other concurrent experimental drugs * No concurrent bisphosphonates unless initiated more than 3 months prior to study * Chronic use allowed provided bone metastases are not sole indicator lesions
References
Publications (2)
- DERIVEDEppenberger-Castori S, Klingbiel D, Ruhstaller T, Dietrich D, Rufle DA, Rothgiesser K, Pagani O, Thurlimann B. Plasma HER2ECD a promising test for patient prognosis and prediction of response in HER2 positive breast cancer: results of a randomized study - SAKK 22/99. BMC Cancer. 2020 Feb 11;20(1):114. doi: 10.1186/s12885-020-6594-0. PMID 32046665
- DERIVEDSchmid S, Klingbiel D, Aebi S, Goldhirsch A, Mamot C, Munzone E, Nole F, Oehlschlegel C, Pagani O, Pestalozzi B, Rochlitz C, Thurlimann B, von Moos R, Weder P, Zaman K, Ruhstaller T. Long-term responders to trastuzumab monotherapy in first-line HER-2+ advanced breast cancer: characteristics and survival data. BMC Cancer. 2019 Sep 10;19(1):902. doi: 10.1186/s12885-019-6105-3. PMID 31500588