Clinical trial · Interventional
Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer
Neoadjuvant Administration of Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Large or Locally Advanced Operable Breast Cancer: A Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine+Doxorubicin+Cisplatin+Surgery
- description
- Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8). Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
- interventionNames
- Drug: gemcitabine
- Drug: doxorubicin
- Drug: cisplatin
- Procedure: surgery
Primary outcomes (1)
- measure
- Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)
- timeFrame
- tumor assessment at baseline and during surgery after eight 21-day treatment cycles
- description
- Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of breast carcinoma * No previous chemotherapy, with bidimensionally measurable locally advanced disease * Adequate performance status (Karnofsky Performance Status \[KPS\] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions. Exclusion Criteria: * Inflammatory breast cancer * Pregnancy and Breast-feeding * Serious concomitant disorder or infection * Previous cancer within the last 5 years or a second primary malignancy.
References
Publications (0)
Data not yet available