Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Phase IV Trial Evaluating the Palliative Benefit of Either Continuing Pamidronate or Switching to Second-line Zoledronic Acid in Breast Cancer Patients With High-risk Bone Metastases.
Brief Summary: Metastatic breast cancer patients with bone involvement who are at high-risk of subsequent skeletal related event (SRE), defined as radiotherapy or surgery to the bone, pathological fracture, spinal cord compression, or hypercalcemia (as reflected through: elevated sCTX or bone pain or a prior SRE despite receiving standard bisphosphonate therapy) should experience a decrease in the surrogate marker, sCTX, at week 12 if switched to zoledronic acid compared with those patients who continue on intravenous pamidronate (i.e. current standard of care). The investigators propose that a drop in sCTX will correlate with improved pain, quality of life and a reduced incidence of further SREs.


Options:
A: Arm Label: Pamidronate and placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pamidronate, Drug: placebo | Arm Label: Zoledronic acid and placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Zoledronic acid, Drug: placebo | Intervention Type: DRUG; Name: Pamidronate; Assigned to Arm(s): Pamidronate and placebo | Intervention Type: DRUG; Name: Zoledronic acid; Assigned to Arm(s): Zoledronic acid and placebo | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Pamidronate and placebo, Zoledronic acid and placebo
B: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: 5-FU, Epirubicin, Cyclophosphamide, Docetaxel | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: 5-FU, Epirubicin, Cyclophosphamide, Docetaxel, Zoledronic acid | Intervention Type: DRUG; Name: 5-FU, Epirubicin, Cyclophosphamide, Docetaxel; Assigned to Arm(s): A | Intervention Type: DRUG; Name: 5-FU, Epirubicin, Cyclophosphamide, Docetaxel, Zoledronic acid; Assigned to Arm(s): B
C: Arm Label: Arm 1: Clodronate; Type: EXPERIMENTAL; Interventions: Drug: clodronate | Arm Label: Arm 2: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: clodronate; Assigned to Arm(s): Arm 1: Clodronate | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Arm 2: Placebo
D: Arm Label: Zometa; Type: EXPERIMENTAL; Interventions: Drug: Zometa, Drug: Epirubicin, Drug: Docetaxel, Drug: Trastuzumab, Radiation: External beam radiation, Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection | Arm Label: No Zometa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Epirubicin, Drug: Docetaxel, Drug: Trastuzumab, Radiation: External beam radiation, Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection | Intervention Type: DRUG; Name: Zometa; Assigned to Arm(s): Zometa | Intervention Type: DRUG; Name: Epirubicin; Assigned to Arm(s): No Zometa, Zometa | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): No Zometa, Zometa | Intervention Type: DRUG; Name: Trastuzumab; Assigned to Arm(s): No Zometa, Zometa | Intervention Type: RADIATION; Name: External beam radiation; Assigned to Arm(s): No Zometa, Zometa | Intervention Type: PROCEDURE; Name: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection; Assigned to Arm(s): No Zometa, Zometa

Answer: A