Proluton Study

A phase III randomized controlled study of Inj. Proluton (Hydorxyprogesterone Caproate) as a single dose preoperative therapy in patients with high risk operable breast cancer( Proluton Study)

Study design / Type : Phase III randomized trial

A randomized prospective trial was initiated in 1997 at Tata Memorial Hospital, Mumbai, India to compare effects of primary progesterone prior to surgery versus standard care in women with early breast cancer with disease-free survival as the primary end-point.

At a median follow up of 65 months among 976 eligible patients, 273 recurrences and 202 deaths were recorded. In progesterone versus control groups, 5-year DFS and OS were 73.9% versus 70.2% and 80.2% versus 78.4% respectively.

Based on the above results, and the fact that the study was carried out in a single institution, it was required to be replicated at other centres as well.

It was proposed to carry out the study as a multicentre study in different geographical areas in women with high risk (and node positive) operable breast cancer with a primary objective to see the effect of Inj. Proluton (Hydroxyprogesterone caproate) on Disease-free survival (DFS) at 5 years & secondary objective to see the effect of Inj. Proluton (Hydroxyprogesterone caproate) on Overall survival (OS) at 5 years.

Study design:

Patients with operable breast cancer diagnosed by FNAC or Trucut biopsy with clinical stages T2/T3 and clinically or radiological N+ will be included in the study. Patients will be stratified, before randomization for Tumor size, and menopausal status. Centres where facility for FNAC/Trucut biopsy is not available can randomize patients on clinical certainty. These patients will then be randomized 1:1 to receive the following 

1. Single injection of Depot Inj. Progesterone (Hydroxyprogetserone caproate) 500 mg deep IM 5-15 days prior to surgery including the day of surgery (Study treatment)

    OR

2. Standard Treatment (Control)

These patients will undergo standard surgical treatment anytime between 5 to 14 days after the injection. In case the surgery is delayed beyond 14 days, 250 mgs of inj. Proluton will be administered and surgery will be carried out within 1 week of the repeated dose.

All patients will thereafter receive standard post-operative adjuvant therapy as per local institutional practice including hormonal therapy, chemotherapy and radiation therapy. 

Target patient population